Trial Outcomes & Findings for An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies (NCT NCT02265510)
NCT ID: NCT02265510
Last Updated: 2020-04-17
Results Overview
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
83 participants
Primary outcome timeframe
From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
Results posted on
2020-04-17
Participant Flow
Participants took part in the study at 11 investigative sites in United States from 10 September 2014 to 27 February 2019. This study was prematurely terminated due to lack of efficacy.
Participants with advanced malignancies,acute myeloid leukemia(AML),high-risk myelodysplastic syndrome(MDS)who failed prior therapy with hypomethylating agents(HMA)enrolled to dose escalation(Part 1),expansion(Part 2) of INCB052793 monotherapy and combination therapy cohorts.CohortsA,C,D,E,G,H had no enrollment at the time of premature termination.
Participant milestones
| Measure |
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle.
|
Hase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle.
|
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle.
|
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
4
|
3
|
6
|
3
|
4
|
4
|
7
|
5
|
16
|
9
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
4
|
3
|
6
|
3
|
4
|
4
|
7
|
5
|
16
|
9
|
10
|
Reasons for withdrawal
| Measure |
Phase 1a TGA - INCB052793 15 mg
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle.
|
Hase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle.
|
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle.
|
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
1
|
0
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
2
|
0
|
2
|
2
|
1
|
3
|
2
|
1
|
3
|
3
|
4
|
12
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
2
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
1
|
4
|
1
|
2
|
Baseline Characteristics
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 25 mg
n=3 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=6 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=4 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 75 mg
n=3 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 100 mg
n=6 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 25 mg
n=3 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 35 mg
n=4 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGB - INCB052793 50 mg
n=4 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=7 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle.
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
n=5 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle.
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=16 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=9 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
• Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
n=10 Participants
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 8.08 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 9.85 • n=7 Participants
|
57.0 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 13.40 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 15.13 • n=21 Participants
|
63.0 years
STANDARD_DEVIATION 10.77 • n=10 Participants
|
60.3 years
STANDARD_DEVIATION 6.66 • n=115 Participants
|
58.5 years
STANDARD_DEVIATION 6.45 • n=24 Participants
|
56.3 years
STANDARD_DEVIATION 3.69 • n=42 Participants
|
60.3 years
STANDARD_DEVIATION 13.84 • n=42 Participants
|
62.8 years
STANDARD_DEVIATION 14.17 • n=42 Participants
|
64.4 years
STANDARD_DEVIATION 15.47 • n=42 Participants
|
70.4 years
STANDARD_DEVIATION 5.64 • n=36 Participants
|
71.2 years
STANDARD_DEVIATION 8.50 • n=36 Participants
|
62.6 years
STANDARD_DEVIATION 12.31 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
29 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
54 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
70 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American-Indian/Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Missing
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
78 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)Population: Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=3 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=6 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=4 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
n=3 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
n=6 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
n=3 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
n=4 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
n=4 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=7 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
n=5 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=16 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
TEAE
|
3 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
16 Participants
|
|
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
SAE
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study (Up to approximately 4.5 years)Population: Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=6 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=3 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=8 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=2 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through end of study (Up to approximately 4.5 years)Population: Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=25 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=4 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=4 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=3 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
n=7 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
n=12 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
n=7 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
n=2 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)Population: Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=9 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=10 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With at Least One TEAE and SAE
TEAE
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2: Number of Participants With at Least One TEAE and SAE
SAE
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=7 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=7 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
n=3 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
n=3 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
n=15 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=8 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
|
522 nM
Standard Deviation 126
|
1110 nM
Standard Deviation 324
|
1120 nM
Standard Deviation 543
|
2050 nM
Standard Deviation 1070
|
1840 nM
Standard Deviation 563
|
2890 nM
Standard Deviation 1690
|
928 nM
Standard Deviation 263
|
1270 nM
Standard Deviation 856
|
1480 nM
Standard Deviation 588
|
1610 nM
Standard Deviation 745
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=7 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=7 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
n=3 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
n=3 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
n=15 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=8 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
|
1.1 hours (hr)
Interval 0.48 to 2.0
|
0.76 hours (hr)
Interval 0.47 to 2.0
|
2.0 hours (hr)
Interval 0.5 to 4.0
|
1.1 hours (hr)
Interval 1.0 to 2.1
|
2.2 hours (hr)
Interval 1.1 to 4.0
|
2.0 hours (hr)
Interval 0.43 to 2.1
|
1.0 hours (hr)
Interval 0.43 to 2.0
|
1.1 hours (hr)
Interval 0.58 to 7.7
|
1.1 hours (hr)
Interval 0.47 to 2.1
|
0.51 hours (hr)
Interval 0.33 to 2.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
n=7 Participants
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
n=7 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
n=3 Participants
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
n=3 Participants
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
n=6 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
n=15 Participants
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=8 Participants
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
|
4750 nM*hr
Standard Deviation 1380
|
9170 nM*hr
Standard Deviation 4290
|
8430 nM*hr
Standard Deviation 2520
|
14700 nM*hr
Standard Deviation 6670
|
18300 nM*hr
Standard Deviation 10600
|
27800 nM*hr
Standard Deviation 12300
|
6390 nM*hr
Standard Deviation 1690
|
9580 nM*hr
Standard Deviation 6710
|
10200 nM*hr
Standard Deviation 5260
|
9380 nM*hr
Standard Deviation 4390
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=9 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
|
1310 nM
Standard Deviation 638
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
Tmax is the time to maximum (peak) observed plasma drug concentration.
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=9 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
|
3.5 hr
Interval 1.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2Population: The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Outcome measures
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=9 Participants
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria.
|
Phase 1a TGA - INCB052793 35 mg
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 75 mg
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGA - INCB052793 100 mg
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 25 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 35 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1a TGB - INCB052793 50 mg
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 21-day cycle
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
|
9870 nM*hr
Standard Deviation 7350
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Cmax is defined as the maximum observed plasma concentration measured at Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study
Tmax is the time to maximum (peak) observed plasma drug concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Data was not collected as no participants were enrolled in Part 2 of the study
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Data was not collected as no participants were enrolled in Part 2 of the study
Minimum observed plasma concentration measured at steady state (Day 15).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Data was not collected as no participants were enrolled in Part 2 of the study
Tmax is the time to maximum (peak) observed plasma drug concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Data was not collected as no participants were enrolled in Part 2 of the study
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 15Population: Data was not collected as no participants were enrolled in Part 2 of the study
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study.
Tmax is the time to maximum (peak) observed plasma drug concentration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study.
AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2, Day 1Population: Data was not collected as no participants were enrolled in Part 2 of the study
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1a TGA - INCB052793 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1a TGA - INCB052793 25 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a TGA - INCB052793 35 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1a TGA - INCB052793 50 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1a TGA - INCB052793 75 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1a TGA - INCB052793 100 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 1a TGB - INCB052793 25 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1a TGB - INCB052793 35 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1a TGB - INCB052793 50 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
Serious events: 14 serious events
Other events: 16 other events
Deaths: 12 deaths
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
Serious events: 7 serious events
Other events: 9 other events
Deaths: 7 deaths
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
Serious events: 8 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 participants at risk
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
|
Phase 1a TGA - INCB052793 25 mg
n=3 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
|
Phase 1a TGA - INCB052793 35 mg
n=6 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
|
Phase 1a TGA - INCB052793 50 mg
n=4 participants at risk
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
|
Phase 1a TGA - INCB052793 75 mg
n=3 participants at risk
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
|
Phase 1a TGA - INCB052793 100 mg
n=6 participants at risk
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
|
Phase 1a TGB - INCB052793 25 mg
n=3 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 248.7 days).
|
Phase 1a TGB - INCB052793 35 mg
n=4 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 342.8 days).
|
Phase 1a TGB - INCB052793 50 mg
n=4 participants at risk
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 76.3 days).
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=7 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 28-day cycle (Up to mean duration of exposure of approximately 53.6 days).
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
n=5 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 151.2 days).
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=16 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 142.1 days).
|
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=9 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 86.2 days).
|
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
n=10 participants at risk
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 143 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
42.9%
3/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
80.0%
4/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
56.2%
9/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
5/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
42.9%
3/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Fatigue
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
myocardial ischaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
Other adverse events
| Measure |
Phase 1a TGA - INCB052793 15 mg
n=3 participants at risk
INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ).
|
Phase 1a TGA - INCB052793 25 mg
n=3 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days).
|
Phase 1a TGA - INCB052793 35 mg
n=6 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days).
|
Phase 1a TGA - INCB052793 50 mg
n=4 participants at risk
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days).
|
Phase 1a TGA - INCB052793 75 mg
n=3 participants at risk
INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days).
|
Phase 1a TGA - INCB052793 100 mg
n=6 participants at risk
INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days).
|
Phase 1a TGB - INCB052793 25 mg
n=3 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 248.7 days).
|
Phase 1a TGB - INCB052793 35 mg
n=4 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 342.8 days).
|
Phase 1a TGB - INCB052793 50 mg
n=4 participants at risk
INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 76.3 days).
|
Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
n=7 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 28-day cycle (Up to mean duration of exposure of approximately 53.6 days).
|
Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2
n=5 participants at risk
INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m\^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 151.2 days).
|
Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=16 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 142.1 days).
|
Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
n=9 participants at risk
INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 86.2 days).
|
Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
n=10 participants at risk
Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m\^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m\^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 143 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
60.0%
3/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
8/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
44.4%
4/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Confusional state
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Psychiatric disorders
Mental status changes
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
4/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
44.4%
4/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Fungal skin infection
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Human papilloma virus test positive
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
100.0%
3/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
42.9%
3/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
62.5%
10/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
57.1%
4/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
43.8%
7/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Eye oedema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
5/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
43.8%
7/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
42.9%
3/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
75.0%
3/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Application site pruritus
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Asthenia
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Catheter site bruise
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Catheter site erythema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Chills
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Device occlusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Energy increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Facial pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
2/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
75.0%
3/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
60.0%
3/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
8/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
5/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Injection site bruising
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Injection site pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
60.0%
3/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
44.4%
4/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Localised oedema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Malaise
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Mass
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Medical device pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Nodule
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Oedema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Temperature intolerance
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Immune system disorders
Graft versus host disease in skin
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Empyema
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
37.5%
6/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
66.7%
4/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
31.2%
5/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
44.4%
4/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
3/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood iron increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
3/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
2/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Platelet count increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Reticulocyte count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Serum ferritin increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
18.8%
3/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
40.0%
4/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
22.2%
2/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
55.6%
5/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
42.9%
3/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
50.0%
2/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
28.6%
2/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
30.0%
3/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
16.7%
1/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
12.5%
2/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
2/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
1/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
4/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
11.1%
1/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
20.0%
2/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
6.2%
1/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
25.0%
1/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
14.3%
1/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
33.3%
1/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/6 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/3 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/4 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/7 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/5 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/16 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
0.00%
0/9 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
10.0%
1/10 • From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER