Trial Outcomes & Findings for A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies (NCT NCT01943851)
NCT ID: NCT01943851
Last Updated: 2024-10-01
Results Overview
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Up to 86.9 weeks
Results posted on
2024-10-01
Participant Flow
This was an open-label repeat dose, multicenter study to investigate the safety, pharmacokinetics (PK), pharmacodynamics and clinical activity of GSK525762 in participants with relapsed, refractory hematologic malignancies. The study was conducted in 2 parts: Part 1 (dose escalation) and Part 2 (dose expansion)
A total of 111 participants were enrolled (87 participants in Part 1 and 24 participants in Part 2) across the study centers in Australia, Spain, Great Britain, South Korea and United State of America (USA).
Participant milestones
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
|
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Up to 86.9 Weeks)
STARTED
|
1
|
1
|
1
|
5
|
1
|
4
|
8
|
18
|
3
|
8
|
1
|
7
|
7
|
16
|
6
|
0
|
0
|
0
|
|
Part 1 (Up to 86.9 Weeks)
COMPLETED
|
1
|
1
|
1
|
4
|
0
|
4
|
7
|
16
|
2
|
8
|
1
|
7
|
7
|
15
|
6
|
0
|
0
|
0
|
|
Part 1 (Up to 86.9 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 36.4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
16
|
1
|
|
Part 2 (Up to 36.4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
13
|
0
|
|
Part 2 (Up to 36.4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
3
|
1
|
Reasons for withdrawal
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
Part 2: GSK525762 60 mg QD CTCL
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 2: GSK525762 75 mg QD MDS
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
|
Part 2: GSK525762 80 mg QD CTCL
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Up to 86.9 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to 86.9 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Up to 86.9 Weeks)
Investigator discretion
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 36.4 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 2 (Up to 36.4 Weeks)
Study closed/terminated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
1
|
Baseline Characteristics
A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
Part 2: GSK525762 60 mg QD CTCL
n=7 Participants
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 2: GSK525762 75 mg QD MDS
n=16 Participants
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
|
Part 2: GSK525762 80 mg QD CTCL
n=1 Participants
Participants CTCL were administered once daily oral dose of 80 mg GSK525762
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
51 Participants
n=667 Participants
|
|
Age, Customized
65-74 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
36 Participants
n=667 Participants
|
|
Age, Customized
>74 years
|
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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
24 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
10 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Japanese Heritage(H)/eastAsian (H)/Southeast Asian (H)
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Black or African american
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Native hawaiian or other pacific islander
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
NA 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
|
NA Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
White
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
14 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
15 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Asian and native hawaiian or other pacific islander
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
NA 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
|
NA Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Missing
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
NA Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
NA Participants
n=44 Participants
|
NA Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population consists of all participants that received at least one dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
Non-serious AEs
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
8 Participants
|
18 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
7 Participants
|
7 Participants
|
16 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
12 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
14 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) and AE Leading to Discontinuation (AELD)
AELD
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeksPopulation: All Treated Population
An event was considered DLT if it occurred within first 3weeks of treatment \& met one of following criteria:unless it was clearly established that event is unrelated to treatment:Grade4 neutropenia persisting for \>=7 days/febrile neutropenia not responding to treatment within 24hours, Grade4 thrombocytopenia lasting more than 7day \& not responding to transfusions/Grade3 thrombocytopenia associated with bleeding (\>10milliliter \[mL\]), Drug-related Grade 3/4 non-hematologic toxicity as described in National Cancer Institute-Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 4.0, Drug-related Grade2 non-hematological toxicity, Grade2 Troponin T elevation(central laboratory\>Upper Limit of Normal\[ULN\]),measured on two separate occasions within 48 hours, Treatment delay of 14 days/greater due to unresolved drug-related toxicity,ALT\>=3xULN+bilirubin\>=2xULN(\>35% direct)/Alanine aminotransferase(ALT) between 3-5xULN with bilirubin\<2xULN but with hepatitis symptom/rash/ALT\>=5xULN.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population
Number of participants with dose reductions due to any reason is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Dose Reductions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population
Number of participants with any dose interruptions/ delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Any Dose Interruptions or Delays
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
15 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
13 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, prothrombin international normalized ratio (Pro. INR), albumin, amylase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, triglycerides, alkaline phosphatase (ALP). Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Magnesium,n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Sodium, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Triglycerides, n=1,1,1,4,1,4,3,17,3,6,1,7,6,10,3
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
ALP, n=1,1,1,5,1,4,8,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Cholesterol,n=1,1,1,4,1,4,3,17,3,6,1,7,6,10,3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Glucose, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
16 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
15 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Pro.INR, n=0,1,1,5,1,3,4,16,3,4,0,6,5,11,4
|
—
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
1 Participants
|
3 Participants
|
—
|
4 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
ALT, n=1,1,1,5,1,4,8,18,3,8,1,7,7,15,6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Amylase, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,5
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
AST, n=1,1,1,5,1,4,8,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, n=1,1,1,5,1,4,8,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Calcium, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Calcium Ionized, n=1,1,1,4,1,4,7,17,3,8,1,7,7,15,6
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Creatine Kinase, n=1,1,1,2,1,4,8,18,3,7,1,7,7,16,6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Lipase, n=1,1,1,5,1,4,6,18,3,8,1,7,6,15,6
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Potassium, n=1,1,1,5,1,4,7,18,3,8,1,7,6,16,6
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=7 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Leukocytes, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Hemoglobin, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Lymphocytes, n=1,1,0,5,1,4,7,18,3,8,1,7,7,15,6
|
0 Participants
|
0 Participants
|
—
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
10 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Neutrophils, n=1,1,0,5,1,4,7,18,3,8,1,7,7,15,5
|
0 Participants
|
0 Participants
|
—
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Grade Change From Baseline in Hematology Parameters
Platelets, n=1,1,1,5,1,4,7,18,3,8,1,7,7,16,6
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
17 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=5 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=15 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=5 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Protein, n=1,1,1,4,1,4,2,12,1,5,0,3,4,7,1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
—
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Glucose, n=1,1,1,4,1,4,4,15, 3,5,0,3,5,8,1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Ketones, n=1,1,1,4,1,4,4,13,3,5,1,6,5,11,2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Occult blood, n=1,1,1,4,1,4,5,14,3,7,1,6,5,11,2
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Monoclonal pro, n=0,0,0,0,0,1,0,0,2,0,0,0,0,0,0
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed.
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=7 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse rate, To Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse rate, To Normal or No change
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse Rate, To High
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To Normal or No Change
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To High,
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population.
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=7 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population.
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
Abnormal-Clinically significant
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
Abnormal-Not Clinically significant
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
17 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population
ORR for MDS cohort is defined as the percentage of participants achieving Complete Response (CR), Marrow CR, CRp (as per CR but platelet count \<100 x 10\^9 cells/Liter\[L\]), CRi (as per CR but platelet count \<100 x 10\^9cells/L or neutrophil count \<1 x 10\^9 cells/L), or Partial Response (PR) per response criteria. Complete response is defined as bone marrow \<=5% myeloblasts with normal maturation of all cell lines, with hemoglobin concentration of \>=11 grams per deciliter (g/dL), absolute neutrophil count \>=1 x 10\^9 cells/L, platelet count \>=100x10\^9 cells/L and 0% blasts in the peripheral blood. Marrow CR is defined as Bone marrow \<=5% myeloblasts and decrease by \>=50% over pre-treatment. Objective response rate was determined by the investigator according to international myeloma working group (IMWG) response criteria.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=16 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Objective Response Rate (ORR) (MDS Cohort)
|
25 Percentage of participants
Interval 7.3 to 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
ORR4 for CTCL cohorts is defined as the percentage of participants that have achieved a CR or PR lasting at least 4 months per global response criteria and the modified severity weighted assessment tool (mSWAT). ORR4 and 95% exact confidence interval is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts)
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population.
ORR is defined as the percentage of participants achieving stringent complete response (sCR), very good partial response (VGPR), partial response (PR) or minimal response (MR) for multiple myeloma (MM); CR or PR for Non-Hodgkin's Lymphoma (NHL); CR, CRp, CRi or PR for Acute Myeloid Leukemia (AML); CR, MR or PR for Myelodysplastic Syndrome (MDS) using the International Working Group (IWG) response criteria and IWG response criteria in myelodysplasia.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Overall Response Rate (ORR)- Investigator Assessment
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 60.2
|
25 Percentage of participants
Interval 3.2 to 65.1
|
6 Percentage of participants
Interval 0.1 to 27.3
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 97.5
|
14 Percentage of participants
Interval 0.4 to 57.9
|
29 Percentage of participants
Interval 3.7 to 71.0
|
13 Percentage of participants
Interval 1.6 to 38.3
|
17 Percentage of participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population consisted of all participants in the All Treated Population for whom a PK sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single Dose Administration
AUC(0-24), n=1,1,1,5,1,4,8,18,3,8,1,6,7,16, 6
|
460.48 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant.
|
1024.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2881.41 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2146.54 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.68
|
3317.10 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2510.55 Hours*nanograms per milliliter
Geometric Coefficient of Variation 71.29
|
6424.74 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.42
|
5918.90 Hours*nanograms per milliliter
Geometric Coefficient of Variation 52.85
|
3695.32 Hours*nanograms per milliliter
Geometric Coefficient of Variation 62.01
|
7980.72 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.28
|
5944.52 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
8394.69 Hours*nanograms per milliliter
Geometric Coefficient of Variation 34.31
|
5017.96 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.17
|
13520.57 Hours*nanograms per milliliter
Geometric Coefficient of Variation 46.29
|
13688.54 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.80
|
|
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0-24]) and AUC Extrapolated to Infinity (AUC[0-inf]) of GSK525762 Following Single Dose Administration
AUC(0-inf), n=1,1,1,5,1,4,7,17,3,8,1,5,7,16,5
|
466.81 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1092.28 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
3054.11 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2217.32 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.55
|
3465.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2546.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation 72.05
|
6951.06 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.12
|
6214.97 Hours*nanograms per milliliter
Geometric Coefficient of Variation 60.67
|
3874.05 Hours*nanograms per milliliter
Geometric Coefficient of Variation 63.27
|
8248.45 Hours*nanograms per milliliter
Geometric Coefficient of Variation 47.87
|
6032.36 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
9734.83 Hours*nanograms per milliliter
Geometric Coefficient of Variation 29.60
|
5114.61 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.76
|
14635.17 Hours*nanograms per milliliter
Geometric Coefficient of Variation 52.35
|
17021.44 Hours*nanograms per milliliter
Geometric Coefficient of Variation 35.37
|
SECONDARY outcome
Timeframe: Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. AUC(0-24) represents AUC(0-tau) for repeat dose.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat Dose Administration
AUC(0-24)
|
476.71 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
656.93 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1855.07 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1908.18 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.53
|
2490.25 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1702.37 Hours*nanograms per milliliter
Geometric Coefficient of Variation 58.17
|
6271.43 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.76
|
3576.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation 30.59
|
931.02 Hours*nanograms per milliliter
Geometric Coefficient of Variation 53.64
|
5883.76 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.48
|
5188.25 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
6892.57 Hours*nanograms per milliliter
Geometric Coefficient of Variation 71.96
|
2994.24 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.27
|
9440.98 Hours*nanograms per milliliter
Geometric Coefficient of Variation 84.11
|
5296.46 Hours*nanograms per milliliter
Geometric Coefficient of Variation 8.89
|
|
Part 1: AUC(0-24) and Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK525762 Following Repeat Dose Administration
AUC(0-tau)
|
476.71 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
656.93 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1855.07 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1908.18 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.53
|
2490.25 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1702.37 Hours*nanograms per milliliter
Geometric Coefficient of Variation 58.17
|
6271.43 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.76
|
3576.49 Hours*nanograms per milliliter
Geometric Coefficient of Variation 30.59
|
931.02 Hours*nanograms per milliliter
Geometric Coefficient of Variation 53.64
|
5883.76 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.48
|
5188.25 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
6892.57 Hours*nanograms per milliliter
Geometric Coefficient of Variation 71.96
|
2994.24 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.27
|
9440.98 Hours*nanograms per milliliter
Geometric Coefficient of Variation 84.11
|
5296.46 Hours*nanograms per milliliter
Geometric Coefficient of Variation 8.89
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration
Cmax
|
90.56 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
116.69 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
559.14 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
442.77 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.83
|
513.03 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
660.79 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71.94
|
853.03 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.1
|
1158.66 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28.58
|
813.87 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27.91
|
1728.80 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.37
|
1248.10 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1444.42 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.92
|
1073.51 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38.46
|
2335.99 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 23.05
|
1793.39 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42.16
|
|
Part 1: Maximum Observed Concentration (Cmax) and Minimum Plasma Concentration (Cmin) of GSK525762 Following Single Dose Administration
Cmin
|
1.11 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
27.86 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
20.62 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
7.55 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73.07
|
21.20 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
13.25 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71.79
|
107.30 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 68.40
|
50.49 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 139.83
|
29.39 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.67
|
37.92 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 80.33
|
129.76 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
71.43 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 112.42
|
27.89 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 115.67
|
89.96 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 112.80
|
138.75 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 111.14
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of GSK525762 Following Repeat Dose Administration
Cmax
|
102.86 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
118.59 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
550.01 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
387.66 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52.41
|
557.60 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
566.59 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 57.75
|
1070.32 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37.26
|
1179.42 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28.10
|
512.78 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48.37
|
1384.46 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.35
|
1752.86 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1314.21 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58.58
|
725.29 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46.79
|
1587.25 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 50.83
|
921.35 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52.16
|
|
Part 1: Cmax and Cmin of GSK525762 Following Repeat Dose Administration
Cmin
|
1.47 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
5.03 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
3.92 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
7.72 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 103.48
|
8.66 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2.36 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 84.21
|
57.75 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 82.69
|
7.03 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51.10
|
1.63 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 141.42
|
14.00 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 112.58
|
21.02 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
50.89 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 123.69
|
4.64 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73.29
|
55.63 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 163.06
|
14.96 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 64.95
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose on Days 4, 6 and 7Population: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Trough Concentration (Ctau) of GSK525762 Following Repeat Dose Administration
|
0.91 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
3.90 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
3.76 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
4.88 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 78.94
|
8.12 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
2.26 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 114.63
|
32.85 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 88.47
|
5.99 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41.92
|
0.03 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 128.56
|
13.21 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 102.35
|
2.08 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
15.77 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 123.78
|
2.25 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 92.05
|
42.18 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 139.74
|
14.34 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 68.62
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=18 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time of Maximum Concentration (Tmax) of GSK525762 Following Single Dose Administration
|
0.62 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
2.00 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
1.00 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
1.00 Hour
Interval 0.5 to 1.0
|
1.00 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
0.78 Hour
Interval 0.4 to 2.0
|
1.56 Hour
Interval 0.3 to 2.1
|
1.00 Hour
Interval 0.3 to 4.1
|
1.00 Hour
Interval 0.5 to 2.2
|
0.86 Hour
Interval 0.5 to 2.1
|
1.28 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
1.03 Hour
Interval 0.5 to 2.0
|
1.00 Hour
Interval 0.3 to 1.2
|
0.92 Hour
Interval 0.3 to 4.0
|
1.58 Hour
Interval 0.2 to 4.1
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Tmax of GSK525762 Following Repeat Dose Administration
|
0.67 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
0.00 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
0.83 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
1.26 Hour
Interval 0.5 to 2.0
|
0.50 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
0.78 Hour
Interval 0.5 to 1.2
|
0.58 Hour
Interval 0.5 to 2.0
|
0.50 Hour
Interval 0.3 to 2.0
|
0.63 Hour
Interval 0.3 to 1.0
|
0.60 Hour
Interval 0.3 to 4.0
|
0.50 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
0.98 Hour
Interval 0.5 to 2.0
|
1.06 Hour
Interval 0.6 to 2.0
|
2.00 Hour
Interval 0.5 to 4.0
|
2.33 Hour
Interval 0.5 to 4.2
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=8 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=17 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=5 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=5 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Half Life (T1/2) of GSK525762 Following Single Dose Administration
|
4.01 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
5.75 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
6.27 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.55 Hour
Interval 1.4 to 6.4
|
5.10 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.07 Hour
Interval 3.5 to 4.6
|
6.48 Hour
Interval 5.2 to 10.3
|
3.96 Hour
Interval 2.9 to 9.3
|
5.55 Hour
Interval 1.4 to 8.1
|
4.57 Hour
Interval 3.3 to 6.3
|
4.15 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.75 Hour
Interval 4.1 to 7.4
|
4.06 Hour
Interval 3.0 to 5.8
|
5.66 Hour
Interval 1.9 to 9.7
|
6.53 Hour
Interval 4.7 to 7.5
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for PK analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: T1/2 of GSK525762 Following Repeat Dose Administration
|
3.68 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
5.64 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.70 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.15 Hour
Interval 2.9 to 6.4
|
4.39 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.39 Hour
Interval 3.2 to 5.8
|
6.48 Hour
Interval 3.4 to 7.8
|
3.51 Hour
Interval 3.0 to 5.3
|
1.96 Hour
Interval 1.7 to 2.3
|
3.97 Hour
Interval 3.1 to 5.3
|
2.54 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
4.98 Hour
Interval 2.4 to 5.9
|
3.22 Hour
Interval 2.2 to 3.7
|
5.51 Hour
Interval 3.2 to 8.6
|
4.09 Hour
Interval 3.8 to 4.4
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=10 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=1 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time Invariance (RS) of GSK525762
|
1.02 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.60 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.61 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.71 Ratio
Geometric Coefficient of Variation 35.82
|
0.72 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.67 Ratio
Geometric Coefficient of Variation 18.60
|
0.98 Ratio
Geometric Coefficient of Variation 11.73
|
0.65 Ratio
Geometric Coefficient of Variation 31.37
|
0.32 Ratio
Geometric Coefficient of Variation 53.56
|
0.78 Ratio
Geometric Coefficient of Variation 46.56
|
0.86 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.91 Ratio
Geometric Coefficient of Variation 36.22
|
0.74 Ratio
Geometric Coefficient of Variation 19.36
|
0.76 Ratio
Geometric Coefficient of Variation 84.74
|
0.54 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=1 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
n=1 Participants
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=4 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
n=3 Participants
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
n=1 Participants
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
n=5 Participants
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
n=2 Participants
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Accumulation Ratio (RO) of GSK525762
|
1.04 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.64 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.64 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.74 Ratio
Geometric Coefficient of Variation 36.67
|
0.75 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
0.68 Ratio
Geometric Coefficient of Variation 17.66
|
1.06 Ratio
Geometric Coefficient of Variation 13.47
|
0.67 Ratio
Geometric Coefficient of Variation 29.24
|
0.33 Ratio
Geometric Coefficient of Variation 47.64
|
0.81 Ratio
Geometric Coefficient of Variation 45.70
|
0.87 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1.01 Ratio
Geometric Coefficient of Variation 33.69
|
0.75 Ratio
Geometric Coefficient of Variation 20.27
|
0.81 Ratio
Geometric Coefficient of Variation 82.45
|
0.71 Ratio
Geometric Coefficient of Variation 24.96
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QC CTCL arm for this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=17 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Clearance (CL/F) of GSK525762 After Single Dose Administration
|
11.80 Liters per hour
Standard Deviation 3.39
|
7.98 Liters per hour
Standard Deviation 3.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=8 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Clearance (CL/F) of GSK525762 After Repeat Dose Administration
|
11.80 Liters per hour
Standard Deviation 3.39
|
9.33 Liters per hour
Standard Deviation 4.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QC CTCL arm for this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=17 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Single Dose Administration
|
51.5 Liters
Standard Deviation 19.50
|
47.9 Liters
Standard Deviation 8.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3 Day 1: pre-dose and at 0.5 - 2 hour, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK525762 were collected at the indicated time points. PK parameters were calculated by empirical Bayes estimates. GSK525762 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=8 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK525762 Following Repeat Dose Administration
|
51.5 Liters
Standard Deviation 19.50
|
45.8 Liters
Standard Deviation 9.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for PK analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=15 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=6 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=15 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
AUC(0-24), n=0,0,0,5,0,1,0,15, 2,8,0,0,6,15,0
|
—
|
—
|
—
|
1368.11 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.39
|
—
|
1891.48 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
3048.33 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.85
|
3297.95 Hours*nanograms per milliliter
Geometric Coefficient of Variation 68.31
|
3174.42 Hours*nanograms per milliliter
Geometric Coefficient of Variation 40.63
|
—
|
—
|
3432.89 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.76
|
2901.79 Hours*nanograms per milliliter
Geometric Coefficient of Variation 52.33
|
—
|
|
Part 1: AUC(0-24) and AUC[0-inf] of GSK3529246 (Active Metabolite) Following Single Dose Administration
AUC(0-inf), n=0,0,0,5,0,1,0,10, 2,7,0,0,6,7,0
|
—
|
—
|
—
|
1691.75 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.96
|
—
|
2013.33 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
3684.96 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.50
|
4499.65 Hours*nanograms per milliliter
Geometric Coefficient of Variation 72.79
|
4003.48 Hours*nanograms per milliliter
Geometric Coefficient of Variation 42.09
|
—
|
—
|
3908.15 Hours*nanograms per milliliter
Geometric Coefficient of Variation 41.20
|
4714.85 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.39
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762. AUC(0-tau) is AUC(0-24) for repeat dose.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=10 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC(0-24) and AUC(0-tau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
AUC(0-24)
|
—
|
—
|
—
|
1517.96 Hours*nanograms per milliliter
Geometric Coefficient of Variation 33.88
|
—
|
1922.77 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
4870.28 Hours*nanograms per milliliter
Geometric Coefficient of Variation 46.15
|
3838.35 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.18
|
5312.66 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.30
|
—
|
—
|
3379.85 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.24
|
8534.92 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.93
|
—
|
|
Part 1: AUC(0-24) and AUC(0-tau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
AUC(0-tau)
|
—
|
—
|
—
|
1517.96 Hours*nanograms per milliliter
Geometric Coefficient of Variation 33.88
|
—
|
1922.77 Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
4870.28 Hours*nanograms per milliliter
Geometric Coefficient of Variation 46.15
|
3838.35 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.18
|
5312.66 Hours*nanograms per milliliter
Geometric Coefficient of Variation 45.30
|
—
|
—
|
3379.85 Hours*nanograms per milliliter
Geometric Coefficient of Variation 44.24
|
8534.92 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.93
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=15 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Single Dose Administration
Cmin, n=0,0,0,2,0,1, 0,14,3,7,0,0,6,13,0
|
—
|
—
|
—
|
2.47 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 4.29
|
—
|
66.39 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
18.17 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 116.63
|
10.83 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 161.52
|
18.45 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71.98
|
—
|
—
|
12.66 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 108.08
|
14.17 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 99.02
|
—
|
|
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Single Dose Administration
Cmax, n=0,0,0,5,0,1, 0,15,3,8,0,0,7,16,0
|
—
|
—
|
—
|
109.45 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45.38
|
—
|
246.12 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
239.98 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.75
|
361.30 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 54.77
|
251.73 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49.71
|
—
|
—
|
325.42 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.17
|
201.02 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.94
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Cmax
|
—
|
—
|
—
|
121.83 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.75
|
—
|
282.72 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
453.89 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34.07
|
500.61 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.83
|
445.47 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 52.02
|
—
|
—
|
370.67 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.23
|
557.92 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.81
|
—
|
|
Part 1: Cmax and Cmin of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
Cmin
|
—
|
—
|
—
|
27.14 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28.38
|
—
|
15.18 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
66.49 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 81.56
|
40.88 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 45.39
|
73.60 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 88.34
|
—
|
—
|
38.71 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56.34
|
116.62 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 74.25
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose on Days 4, 6 and 7Population: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=10 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Trough Concentration (Ctau) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
|
—
|
—
|
—
|
22.48 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.13
|
—
|
13.26 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
64.57 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 77.46
|
40.42 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.96
|
76.23 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 62.65
|
—
|
—
|
28.29 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 94.01
|
178.76 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69.25
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=15 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=3 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=7 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=16 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Single Dose Administration
|
—
|
—
|
—
|
1.92 Hour
Interval 0.9 to 4.1
|
—
|
0.58 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
—
|
2.10 Hour
Interval 0.5 to 8.0
|
4.00 Hour
Interval 2.0 to 4.2
|
3.15 Hour
Interval 1.2 to 4.1
|
—
|
—
|
2.08 Hour
Interval 0.3 to 4.2
|
4.03 Hour
Interval 2.0 to 17.5
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=11 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Tmax of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
|
—
|
—
|
—
|
2.48 Hour
Interval 1.0 to 4.0
|
—
|
0.60 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual Tmax for this single participant.
|
—
|
1.03 Hour
Interval 0.5 to 4.0
|
1.00 Hour
Interval 1.0 to 1.0
|
2.05 Hour
Interval 0.6 to 4.0
|
—
|
—
|
2.02 Hour
Interval 1.2 to 4.1
|
4.00 Hour
Interval 0.9 to 10.1
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Pharmacokinetic parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=5 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=11 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=6 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Single Dose Administration
|
—
|
—
|
—
|
9.90 Hour
Interval 5.2 to 13.4
|
—
|
5.83 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant.
|
—
|
8.66 Hour
Interval 6.7 to 14.1
|
12.72 Hour
Interval 11.5 to 13.9
|
8.31 Hour
Interval 5.4 to 15.7
|
—
|
—
|
7.16 Hour
Interval 6.3 to 9.1
|
9.23 Hour
Interval 5.1 to 15.7
|
—
|
SECONDARY outcome
Timeframe: Week 2 Day 7: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=2 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=8 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: T1/2 of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
|
—
|
—
|
—
|
8.24 Hour
Interval 7.7 to 10.0
|
—
|
6.19 Hour
Full range is not applicable due to single participant, and the median value presented here is the actual t1/2 for this single participant
|
—
|
7.97 Hour
Interval 5.7 to 12.4
|
7.39 Hour
Interval 7.3 to 7.5
|
8.00 Hour
Interval 5.8 to 10.5
|
—
|
—
|
6.72 Hour
Interval 4.0 to 8.7
|
11.77 Hour
Interval 6.9 to 23.8
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. RS was calculated by taking ratio of AUC(0-24) on Week 2 Day 7 to AUC(0-inf) on Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=8 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=6 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time Invariance (RS) of GSK3529246 (Active Metabolite)
|
—
|
—
|
—
|
0.92 Ratio
Geometric Coefficient of Variation 25.58
|
—
|
0.96 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
1.18 Ratio
Geometric Coefficient of Variation 32.33
|
0.63 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1.20 Ratio
Geometric Coefficient of Variation 13.74
|
—
|
—
|
1.06 Ratio
Geometric Coefficient of Variation 9.48
|
1.87 Ratio
Geometric Coefficient of Variation 57.15
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose; Week 2 Day 7: pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed. Plasma samples were not collected for analysis of GSK3529246 (active metabolite) for cohort GSK525762 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD AML, 80 mg QD, 80 mg QD AML, 120 mg QD AML.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. Accumulation ratio was calculated by taking ratio of AUC(0-24) in Week 2 Day 7 to AUC (0-24) in Week 1 Day 1. PK parameters were calculated by standard non-compartmental analysis. GSK3529246 is a metabolite of GSK525762.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
n=4 Participants
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
n=9 Participants
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
n=1 Participants
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
n=7 Participants
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
n=4 Participants
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
n=9 Participants
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Accumulation Ratio (RO) of GSK3529246 (Active Metabolite)
|
—
|
—
|
—
|
1.18 Ratio
Geometric Coefficient of Variation 25.71
|
—
|
1.02 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
—
|
1.61 Ratio
Geometric Coefficient of Variation 31.61
|
0.90 Ratio
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be calculated for a single participant
|
1.56 Ratio
Geometric Coefficient of Variation 26.04
|
—
|
—
|
1.20 Ratio
Geometric Coefficient of Variation 11.50
|
3.22 Ratio
Geometric Coefficient of Variation 59.05
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QC CTCL.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. PK parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=17 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
|
16.5 Liters per hour
Standard Deviation 7.71
|
15.8 Liters per hour
Standard Deviation 6.97
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=8 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Clearance (CL/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
|
15.9 Liters per hour
Standard Deviation 7.26
|
14.6 Liters per hour
Standard Deviation 8.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N" of 75 mg arm within this outcome measure is greater than overall "N" for 75 mg QD MDS \& N=0 for 80 mg QD CTCL.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=17 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Single Dose Administration
|
80.0 Liters
Standard Deviation 37.1
|
71.5 Liters
Standard Deviation 28.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3 Day 1: pre-dose and at 0.5 - 2 hours, 4 - 8 hours post-dosePopulation: PK Population. Given only one participant at 80 mg for single dose data, population PK analysis of combined data from 75 mg QD and 80 mg QD CTCL was more appropriate. Hence the single participant of 80 mg QD arm was included in 75 mg QD MDS arm which leads to "N=0" for 80 mg QD arm within this outcome measure.
Plasma samples for pharmacokinetic (PK) analysis of GSK3529246 (active metabolite) were collected at the indicated time points. GSK3529246 is a metabolite of GSK525762. Pharmacokinetic parameters were calculated by empirical Bayes estimates. GSK3529246 plasma concentration-time data was analyzed by Population PK methods using a non-linear mixed-effects modelling approach.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=8 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Central Volume of Distribution (V1/F) of GSK3529246 (Active Metabolite) Following Repeat Dose Administration
|
80.0 Liters
Standard Deviation 37.1
|
63.4 Liters
Standard Deviation 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (pre-dose Week1 Day1) and Week 3, Week 7, Week 10, Week 16 and Week 24Population: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
The effects of treatment on disease-related symptoms/quality of life was assessed using the Skindex-29 Questionnaire, which inquires about how often (Never, Rarely, Sometimes, Often, All the time) during the previous 4 weeks the participant experienced the effect described in each of 29 items divided into 3 domains: Emotional (10 items), Symptoms (7 items) and Functioning (12 items). Responses to each item are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time). Skindex-29 scores were reported as three individual domain scale scores; a scale score is the mean of a participant's responses to items in a given domain. Each domain score ranges from 0 (no effect) to 100 (effect experienced all the time), higher score implies higher impact of skin disease. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is defined is post-dose visit value minus Baseline.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=6 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=1 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Emotional score, Week 3, n=6,1
|
-5.83 Scores on a scale
Standard Deviation 15.221
|
9.17 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for a single participant
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Emotional score, Week 7, n=5,0
|
-19.50 Scores on a scale
Standard Deviation 22.735
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Emotional score, Week 10, n=3,0
|
-44.17 Scores on a scale
Standard Deviation 26.497
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Emotional score, Week 16, n=3,0
|
-10.00 Scores on a scale
Standard Deviation 10.897
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
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—
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—
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—
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—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Functioning score, Week 3, n=6,1
|
-1.42 Scores on a scale
Standard Deviation 7.742
|
30.87 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for a single participant
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
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—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Functioning score, Week 7, n=5,0
|
-13.37 Scores on a scale
Standard Deviation 23.000
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Functioning score, Week 10, n=3,0
|
-35.67 Scores on a scale
Standard Deviation 27.820
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Functioning score, Week 16, n=3,0
|
-13.45 Scores on a scale
Standard Deviation 9.788
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Functioning score, Week 24, n=2,0
|
-18.84 Scores on a scale
Standard Deviation 11.919
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Symptoms score, Week 3, n=6,1
|
6.55 Scores on a scale
Standard Deviation 24.055
|
12.50 Scores on a scale
Standard Deviation NA
Standard deviation could not be calculated for a single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Symptoms score, Week 7, n=5,0
|
-2.14 Scores on a scale
Standard Deviation 18.489
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Symptoms score, Week 10, n=3,0
|
-29.76 Scores on a scale
Standard Deviation 20.927
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Symptoms score, Week 16, n=3,0
|
-8.33 Scores on a scale
Standard Deviation 19.670
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Symptoms score, Week 24, n=2,0
|
-14.29 Scores on a scale
Standard Deviation 10.102
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Change From Baseline in Skindex-29 Domain Scores (Emotional, Functioning and Symptoms Score) for CTCL Cohort
Emotional score, Week 24, n=2,0
|
-18.75 Scores on a scale
Standard Deviation 1.768
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
Non-serious AEs
|
7 Participants
|
16 Participants
|
1 Participants
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
SAEs
|
5 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
AELD
|
0 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
Number of participants with dose reductions due to any reason is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Dose Reductions
|
6 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
Number of participants with any dose interruptions or delays is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Dose Interruptions/Delays
|
7 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Blood samples were collected for the analysis of following clinical chemistry parameters: glucose, Prothrombin international normalized ratio (Pro. INR), albumin, amylase, ALT, AST, bilirubin, calcium, calcium ionized, cholesterol, creatinine, creatine kinase, lipase, potassium, magnesium, sodium, Triglycerides, ALP. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase was defined as an increase relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Glucose, n=7,16,1
|
6 Participants
|
14 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Pro.INR, n=4,13,0
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, n=7,16,1
|
1 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
ALT, n=7,16,1
|
4 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Amylase, n=7,15,1
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
AST, n=7,15,1
|
3 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, n=7,16,1
|
3 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Calcium, n=7,16,1
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Calcium Ionized, n=7,16,1
|
2 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Cholesterol, n=7,15,1
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Creatine Kinase, n=5,11,1
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, n=7,16,1
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Lipase, n=7,13,1
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Potassium, n=7,16,1
|
1 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Magnesium, n=7,16,1
|
2 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Sodium, n=7,16,1
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
Triglycerides, n=7,15,1
|
7 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters
ALP, n=7,16,1
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Higher grade indicates greater severity. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any grade increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Hemoglobin
|
4 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Lymphocytes
|
4 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Neutrophils
|
2 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Platelets
|
5 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Grade Change From Baseline in Hematology Parameters
Leukocytes
|
1 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected to assess glucose, ketones, occult blood, urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=12 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Glucose, n=5,12,1
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Ketones, n=7,12,1
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Occult blood, n=7,8,1
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Protein, n=6,11,1
|
0 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The clinical concern ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged, or whose value became normal, were recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse rate, To Low
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse rate, To Normal or No change
|
3 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Pulse Rate, To High
|
3 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To Normal or No Change
|
5 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to Baseline: Pulse Rate and Body Temperature
Temperature, To High
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: DBP and SBP
DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: DBP and SBP
SBP
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
Abnormal-Clinically significant
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
Abnormal-Not Clinically significant
|
6 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
PFS defined as interval of time(in months) between date of first dose \& earlier of date of disease progression \& date of death due to any cause.Progression is participants(pt's)with MDS \& with \<5% blasts:\>=50% increase in blasts to\>5% blasts/pt's with 5-10% blasts:\>=50% increase to \>10% blasts, for pt's with 10-20% blasts:\>=50% increase to \>20% blasts,for pt's with 20%-30% blasts:\>=50% increase to \>30% blasts, for CTCL progression is \>=25% increase in skin disease from Baseline/new tumors (T3\[1 or more tumors(\>=1cm diameter\]) in pt's with T1(Limited patches,papules\&/or plaques covering \<10% of the skin surface;may further stratify into T1a \[patch only\] versus T1b \[plaque+-patch\]),T2(Patches,papules/plaques covering \>=10% of skin surface;may further stratify into T2a\[patch only\]versus T2b \[plaque+-patch\]) orT4(Confluence of erythema covering \>=80% body surface area) only skin disease/loss of response in those with CR/PR, increase of skin score of \> sum of nadir +50% Baseline score.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Progression Free Survival (PFS)
|
8.15 Months
Interval 3.48 to
Third quartile could not be calculated
|
2.00 Months
Interval 1.45 to 3.48
|
NA Months
No event occurred for single participant hence Median and Inter-quartile range could not be calculated
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All treated Population. Only those participants with data available at the specified data points were analyzed. Participants with incomplete response rates were excluded from the analysis hence N=0 for 60 mg QD and 80 mg QD CTCL arms.
Duration of response is defined as the time from the first documented evidence response (CR or PR lasting 4 months for CTCL; and CR, marrow CR, CRp, Cri or PR for MDS) until the first documented disease progression or death due to any cause. Median and inter-quartile range (first quartile and third quartile) of duration of response are presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=4 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Duration of Response (DOR)
|
—
|
3.29 Months
Interval 3.29 to 3.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population.
OS is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.
Outcome measures
| Measure |
Part 1: GSK525762 5 mg QD
n=7 Participants
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
Part 1: GSK525762 10 mg QD
n=16 Participants
Participants were administered once daily oral dose of 10 mg GSK525762.
|
Part 1: GSK525762 20 mg QD
n=1 Participants
Participants were administered once daily oral dose of 20 mg GSK525762.
|
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 40 mg QD MM
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Overall Survival (OS)
|
NA Months
Median and inter-quartile range was not reached.
|
5.85 Months
Interval 1.46 to 16.1
|
NA Months
No event occurred for single participant hence Median and Inter-quartile range could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Time to Progression was planned to be analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Changes in QTcF and other safety parameters in relation to GSK525762 PK concentrations was planned to be analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain \[BRD\] proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36.4 weeksPopulation: PK Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Plasma concentrations of GSK525762 in relationship with safety and efficacy parameters derived from PK/PD model was planned to be analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36.4 weeksPopulation: All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Number of participants with dose /exposure markers related change in molecular markers (e.g. gene transcription and/or expression of proteins regulated by Bromodomain proteins) in tumor tissue and/or peripheral blood samples were planned to be analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 86.9 weeksPopulation: All Treated Population. This was an other pre-specified outcome measure. Data was not analyzed and reported.
Overall survival (defined as the interval of time in months between the date of first dose and the date of death due to any cause) was planned to be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
GSK525762 5 MG QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
GSK525762 10 MG QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GSK525762 20 MG QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
GSK525762 30 MG QD MM
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
GSK525762 40 MG QD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GSK525762 40 MG QD MM
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
GSK525762 60 MG QD AML
Serious events: 6 serious events
Other events: 8 other events
Deaths: 7 deaths
GSK525762 60 MG QD NHL
Serious events: 12 serious events
Other events: 18 other events
Deaths: 12 deaths
GSK525762 60 MG QD MM
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
GSK525762 75 MG QD AML
Serious events: 8 serious events
Other events: 8 other events
Deaths: 8 deaths
GSK525762 80 MG QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
GSK525762 80 MG QD AML
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
GSK525762 80 MG QD NHL
Serious events: 7 serious events
Other events: 7 other events
Deaths: 6 deaths
GSK525762 100 MG QD AML
Serious events: 14 serious events
Other events: 16 other events
Deaths: 15 deaths
GSK525762 120 MG QD AML
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
GSK525762 60 MG QD CTCL
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
GSK525762 75 MG QD MDS
Serious events: 12 serious events
Other events: 16 other events
Deaths: 13 deaths
GSK525762 80 MG QD CTCL
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK525762 5 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
GSK525762 10 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 10 mg GSK525762.
|
GSK525762 20 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 20 mg GSK525762.
|
GSK525762 30 MG QD MM
n=5 participants at risk
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
GSK525762 40 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 40 MG QD MM
n=4 participants at risk
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 60 MG QD AML
n=8 participants at risk
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 60 MG QD NHL
n=18 participants at risk
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 60 MG QD MM
n=3 participants at risk
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 75 MG QD AML
n=8 participants at risk
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
GSK525762 80 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 80 MG QD AML
n=7 participants at risk
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 80 MG QD NHL
n=7 participants at risk
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 100 MG QD AML
n=16 participants at risk
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
GSK525762 120 MG QD AML
n=6 participants at risk
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
GSK525762 60 MG QD CTCL
n=7 participants at risk
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 75 MG QD MDS
n=16 participants at risk
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
|
GSK525762 80 MG QD CTCL
n=1 participants at risk
Participants CTCL were administered once daily oral dose of 80 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Genital infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Hyperammonaemic encephalopathy
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Malaise
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
44.4%
8/18 • Number of events 9 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
71.4%
5/7 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Pneumonia
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
31.2%
5/16 • Number of events 11 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Fatigue
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Asthenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Eye disorders
Chalazion
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Chest pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Performance status decreased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Starvation ketoacidosis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Troponin I increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
White blood cell count increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
Other adverse events
| Measure |
GSK525762 5 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
|
GSK525762 10 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 10 mg GSK525762.
|
GSK525762 20 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 20 mg GSK525762.
|
GSK525762 30 MG QD MM
n=5 participants at risk
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
|
GSK525762 40 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 40 MG QD MM
n=4 participants at risk
Participants with MM were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 60 MG QD AML
n=8 participants at risk
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 40 mg GSK525762.
|
GSK525762 60 MG QD NHL
n=18 participants at risk
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 60 MG QD MM
n=3 participants at risk
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 75 MG QD AML
n=8 participants at risk
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
|
GSK525762 80 MG QD
n=1 participants at risk
Participants were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 80 MG QD AML
n=7 participants at risk
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 80 MG QD NHL
n=7 participants at risk
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
|
GSK525762 100 MG QD AML
n=16 participants at risk
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
|
GSK525762 120 MG QD AML
n=6 participants at risk
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
|
GSK525762 60 MG QD CTCL
n=7 participants at risk
Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
|
GSK525762 75 MG QD MDS
n=16 participants at risk
Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762.
|
GSK525762 80 MG QD CTCL
n=1 participants at risk
Participants CTCL were administered once daily oral dose of 80 mg GSK525762.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
38.9%
7/18 • Number of events 8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
4/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
57.1%
4/7 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
68.8%
11/16 • Number of events 15 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
68.8%
11/16 • Number of events 14 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
6/18 • Number of events 7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
4/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
85.7%
6/7 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
8/16 • Number of events 10 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
68.8%
11/16 • Number of events 12 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Blood bilirubin increased
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
4/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
68.8%
11/16 • Number of events 11 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
6/16 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
6/16 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Fatigue
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
6/18 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
57.1%
4/7 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
57.1%
4/7 • Number of events 8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
43.8%
7/16 • Number of events 7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
66.7%
2/3 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
43.8%
7/16 • Number of events 8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
75.0%
3/4 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
44.4%
8/18 • Number of events 8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
6/18 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
8/16 • Number of events 10 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Pyrexia
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
27.8%
5/18 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Asthenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
37.5%
3/8 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
20.0%
1/5 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
25.0%
1/4 • Number of events 5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
3/18 • Number of events 4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
General disorders
Pain
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
40.0%
2/5 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Renal and urinary disorders
Acute kidney injury
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
5.6%
1/18 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
—
0/0 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
11.1%
2/18 • Number of events 2 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/5 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/4 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/18 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/3 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/8 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/7 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/16 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/6 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
0.00%
0/1 • All-cause mortality, non-serious and serious adverse events were collected from the start of study treatment until 28 days following discontinuation of study treatment (up to 86.9 weeks for Part 1 and up to 36.4 weeks for Part 2)
All-cause mortality, non-serious AEs and SAEs were collected in All Treated population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial
- Publication restrictions are in place
Restriction type: OTHER