Trial Outcomes & Findings for Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma (NCT NCT02432235)
NCT ID: NCT02432235
Last Updated: 2021-07-13
Results Overview
A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants): * Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection * CTCAE Grade 4 neutropenia lasting \>7 days * CTCAE Grade 4 thrombocytopenia * CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion * CTCAE Grade 4 anemia A non-hematologic DLT is defined as: * CTCAE Grade 4 tumor lysis syndrome * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia) * CTCAE Grade 3 or higher hypersensitivity reaction * CTCAE Grade 2 or higher skin ulceration * CTCAE Grade 2 or higher peripheral sensory or motor neuropathy
COMPLETED
PHASE1
133 participants
Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)
2021-07-13
Participant Flow
There were 12 sites that screened and enrolled participants: USA: 7 sites; UK: 5 sites.
Participants were included in a screening period of up to 28 days.
Participant milestones
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
3
|
2
|
20
|
41
|
29
|
26
|
3
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
1
|
0
|
8
|
23
|
9
|
5
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
2
|
2
|
12
|
18
|
20
|
21
|
3
|
1
|
1
|
Reasons for withdrawal
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
2
|
2
|
1
|
3
|
11
|
15
|
15
|
3
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
2
|
5
|
3
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Miscellaneous
|
0
|
0
|
0
|
0
|
1
|
6
|
2
|
2
|
4
|
0
|
0
|
1
|
Baseline Characteristics
One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
Baseline characteristics by cohort
| Measure |
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
Total
n=133 Participants
Total of all reporting groups
|
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.0 years
n=1 Participants
|
50.8 years
STANDARD_DEVIATION 17.13 • n=133 Participants
|
73.5 years
STANDARD_DEVIATION 2.12 • n=2 Participants
|
44.0 years
STANDARD_DEVIATION 2.83 • n=2 Participants
|
64.0 years
STANDARD_DEVIATION 12.73 • n=2 Participants
|
51.0 years
STANDARD_DEVIATION 12.53 • n=3 Participants
|
38.0 years
STANDARD_DEVIATION 19.80 • n=2 Participants
|
42.1 years
STANDARD_DEVIATION 16.32 • n=20 Participants
|
45.1 years
STANDARD_DEVIATION 15.48 • n=41 Participants
|
56.3 years
STANDARD_DEVIATION 18.16 • n=29 Participants
|
58.1 years
STANDARD_DEVIATION 15.69 • n=26 Participants
|
58.7 years
STANDARD_DEVIATION 8.08 • n=3 Participants
|
44.5 years
STANDARD_DEVIATION 19.09 • n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
55 Participants
n=133 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
8 Participants
n=20 Participants
|
14 Participants
n=41 Participants
|
15 Participants
n=29 Participants
|
10 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
78 Participants
n=133 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
12 Participants
n=20 Participants
|
27 Participants
n=41 Participants
|
14 Participants
n=29 Participants
|
16 Participants
n=26 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1 Participants
|
13 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=29 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=1 Participants
|
120 Participants
n=133 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
18 Participants
n=20 Participants
|
36 Participants
n=41 Participants
|
26 Participants
n=29 Participants
|
24 Participants
n=26 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
4 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
17 Participants
n=133 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
5 Participants
n=41 Participants
|
1 Participants
n=29 Participants
|
9 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=1 Participants
|
106 Participants
n=133 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
19 Participants
n=20 Participants
|
30 Participants
n=41 Participants
|
28 Participants
n=29 Participants
|
17 Participants
n=26 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
6 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
98 participants
n=133 Participants
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
2 participants
n=2 Participants
|
20 participants
n=20 Participants
|
27 participants
n=41 Participants
|
20 participants
n=29 Participants
|
16 participants
n=26 Participants
|
2 participants
n=3 Participants
|
1 participants
n=2 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=1 Participants
|
35 participants
n=133 Participants
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
0 participants
n=3 Participants
|
0 participants
n=2 Participants
|
0 participants
n=20 Participants
|
14 participants
n=41 Participants
|
9 participants
n=29 Participants
|
10 participants
n=26 Participants
|
1 participants
n=3 Participants
|
1 participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
0 Participants
n=1 Participants
|
43 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=20 Participants
|
16 Participants
n=41 Participants
|
12 Participants
n=29 Participants
|
7 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
1 Participants
n=1 Participants
|
79 Participants
n=133 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
14 Participants
n=20 Participants
|
24 Participants
n=41 Participants
|
13 Participants
n=29 Participants
|
16 Participants
n=26 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
0 Participants
n=1 Participants
|
11 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=29 Participants
|
3 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 4
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 5
|
0 Participants
n=1 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
|
Weight
|
53.20 kilograms (kg)
n=1 Participants
|
80.69 kilograms (kg)
STANDARD_DEVIATION 23.766 • n=133 Participants
|
98.05 kilograms (kg)
STANDARD_DEVIATION 26.517 • n=2 Participants
|
55.25 kilograms (kg)
STANDARD_DEVIATION 12.799 • n=2 Participants
|
80.40 kilograms (kg)
STANDARD_DEVIATION 19.658 • n=2 Participants
|
63.57 kilograms (kg)
STANDARD_DEVIATION 4.840 • n=3 Participants
|
65.05 kilograms (kg)
STANDARD_DEVIATION 14.496 • n=2 Participants
|
79.18 kilograms (kg)
STANDARD_DEVIATION 19.920 • n=20 Participants
|
89.10 kilograms (kg)
STANDARD_DEVIATION 31.926 • n=41 Participants
|
75.15 kilograms (kg)
STANDARD_DEVIATION 18.241 • n=29 Participants
|
78.19 kilograms (kg)
STANDARD_DEVIATION 15.780 • n=26 Participants
|
82.67 kilograms (kg)
STANDARD_DEVIATION 15.808 • n=3 Participants
|
96.50 kilograms (kg)
STANDARD_DEVIATION 12.869 • n=2 Participants
|
|
Height
|
155.00 centimeters (cm)
n=1 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
171.37 centimeters (cm)
STANDARD_DEVIATION 9.920 • n=129 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
176.65 centimeters (cm)
STANDARD_DEVIATION 24.961 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
158.00 centimeters (cm)
STANDARD_DEVIATION 1.414 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
176.00 centimeters (cm)
STANDARD_DEVIATION 4.243 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
170.43 centimeters (cm)
STANDARD_DEVIATION 5.811 • n=3 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
170.20 centimeters (cm)
n=1 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
172.13 centimeters (cm)
STANDARD_DEVIATION 11.212 • n=19 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
172.12 centimeters (cm)
STANDARD_DEVIATION 9.410 • n=39 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
171.43 centimeters (cm)
STANDARD_DEVIATION 9.341 • n=29 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
170.33 centimeters (cm)
STANDARD_DEVIATION 10.188 • n=26 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
173.43 centimeters (cm)
STANDARD_DEVIATION 10.856 • n=3 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
172.50 centimeters (cm)
STANDARD_DEVIATION 13.435 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken.
|
|
Body Mass Index
|
22.14 kg/m^2
n=1 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
27.52 kg/m^2
STANDARD_DEVIATION 7.757 • n=129 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
33.60 kg/m^2
STANDARD_DEVIATION 17.816 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
22.18 kg/m^2
STANDARD_DEVIATION 5.524 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
25.83 kg/m^2
STANDARD_DEVIATION 5.100 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
21.98 kg/m^2
STANDARD_DEVIATION 2.829 • n=3 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
25.99 kg/m^2
n=1 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
26.69 kg/m^2
STANDARD_DEVIATION 4.496 • n=19 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
30.26 kg/m^2
STANDARD_DEVIATION 11.193 • n=39 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
25.37 kg/m^2
STANDARD_DEVIATION 4.913 • n=29 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
26.95 kg/m^2
STANDARD_DEVIATION 4.944 • n=26 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
27.47 kg/m^2
STANDARD_DEVIATION 4.559 • n=3 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
33.07 kg/m^2
STANDARD_DEVIATION 9.447 • n=2 Participants • One participant in the 20 μg/kg group, one participant in the 30 μg/kg group and two participants in the 45 μg/kg group did not have their height measurement taken, and so their Body Mass Index could not be calculated.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)Population: DLT Evaluable Analysis Set: The DLT-evaluable analysis set consisted of participants who completed two cycles of ADCT-301 if enrolled prior to protocol amendment 4 and participants who completed one cycle of ADCT-301 if enrolled after protocol amendment 4. The participants with completed DLT information were included even if they discontinued early before the end of cycle 2 or cycle 1 respectively.
A DLT defined as any of the following, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as (different considerations for Adult T-Cell Leukemia/Lymphoma (ATLL) participants): * Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 febrile neutropenia or neutropenic infection * CTCAE Grade 4 neutropenia lasting \>7 days * CTCAE Grade 4 thrombocytopenia * CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion * CTCAE Grade 4 anemia A non-hematologic DLT is defined as: * CTCAE Grade 4 tumor lysis syndrome * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, electrolyte imbalances lasting ≥ 48 hours despite optimal therapy; excluding all grades of alopecia) * CTCAE Grade 3 or higher hypersensitivity reaction * CTCAE Grade 2 or higher skin ulceration * CTCAE Grade 2 or higher peripheral sensory or motor neuropathy
Outcome measures
| Measure |
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=10 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=15 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=16 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to end of Cycle 1 or 2 (21 day cycle length)Population: Number of participants analyzed presented in the outcome measure data are only those participants in the DLT evaluable analysis set who were dosed at the three dose levels recommended for Part 2.
The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.
Outcome measures
| Measure |
3 μg/kg
n=86 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose of Camidanlumab Tesirine for Part 2
Participants with Hodgkin Lymphoma (Dose level 1: 30 µg/kg)
|
30 μg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Recommended Dose of Camidanlumab Tesirine for Part 2
Participants with Hodgkin Lymphoma (Dose level 2: 45 µg/kg)
|
45 μg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Recommended Dose of Camidanlumab Tesirine for Part 2
Participants with T-cell Lymphoma (80 µg/kg)
|
80 μg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.
Outcome measures
| Measure |
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
41 Participants
|
29 Participants
|
26 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
10 Participants
|
24 Participants
|
14 Participants
|
18 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (a maximum of 12 months after treatment; median time on treatment was 43 days [min 1 day; max 354 days])Population: Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
ORR is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with camidanlumab tesirine. Tumor response was assessed using the 2014 Lugano Classification. CR is defined as achieving each of the following: * Complete metabolic response. * Complete radiologic response (target node regress to \<1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology). PR is defined as achieving each of the following: * Partial metabolic response (findings indicate residual disease). * Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by \>50% in length and no new lesions).
Outcome measures
| Measure |
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=28 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=24 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
32 Participants
|
15 Participants
|
12 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])Population: Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
DoR is defined among responders (complete response \[CR\] and partial response \[PR\]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification. Disease progression is defined as progressive metabolic disease and one of the follow: * Target node progression. * An individual extranodal lesion must be abnormal with length \> 1.5cm and/or increase of length \> 50%. * New or clear progression of nonmeasured lesions. * Regrowth of previously resolved lesions or new nodes \>1.5 cm in length. * New or recurrent bone marrow involvement. DoR is presented overall for all participants who were classed as responders among the efficacy analysis set. Data is pooled for all lymphoma participants for DoR as specified in protocol section 8.4.
Outcome measures
| Measure |
3 μg/kg
n=130 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
5.19 Months
Interval 4.5 to 7.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])Population: Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
Progression-free survival (PFS) is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response. Disease progression is defined as progressive metabolic disease and one of the following: * Target node progression. * An individual extranodal lesion must be abnormal with length \> 1.5cm and/or increase of length \> 50%. * New or clear progression of nonmeasured lesions. * Regrowth of previously resolved lesions or new nodes \> 1.5 cm in length. * New or recurrent bone marrow involvement. PFS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for PFS as specified in protocol section 8.4
Outcome measures
| Measure |
3 μg/kg
n=130 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
5.22 Months
Interval 3.78 to 5.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])Population: Efficacy Analysis Set: The efficacy analysis set consisted of participants who received at least one dose of camidanlumab tesirine with a valid baseline and at least one valid post-baseline disease assessment or participants who had documented progression of disease or death at any time after the first dose of study.
Overall survival (OS) is defined as the time from the first dose of study drug treatment until the date of death due to any cause. OS is presented overall for all participants who received camidanlumab tesirine among the efficacy analysis set. Data is pooled for all lymphoma participants for OS as specified in protocol section 8.4.
Outcome measures
| Measure |
3 μg/kg
n=130 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
16.26 Months
Interval 10.02 to
Insufficient number of participants died during the study, so confidence upper limit could not be calculated.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Cmax for HuMax-TAC, pyrrolobenzodiazepine (PBD) conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=25 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
109 ng/mL
|
62.5 ng/mL
|
131 ng/mL
Geometric Coefficient of Variation 20.7
|
189 ng/mL
Geometric Coefficient of Variation 98.4
|
318 ng/mL
Geometric Coefficient of Variation 82.9
|
603 ng/mL
Geometric Coefficient of Variation 31.8
|
803 ng/mL
Geometric Coefficient of Variation 54.4
|
1120 ng/mL
Geometric Coefficient of Variation 82.8
|
1325 ng/mL
Geometric Coefficient of Variation 43.1
|
1494 ng/mL
Geometric Coefficient of Variation 26.1
|
2671 ng/mL
Geometric Coefficient of Variation 32.9
|
5020 ng/mL
|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
67.5 ng/mL
|
—
|
177 ng/mL
Geometric Coefficient of Variation 39.4
|
254 ng/mL
Geometric Coefficient of Variation 13.1
|
224 ng/mL
|
554 ng/mL
Geometric Coefficient of Variation 48.1
|
1040 ng/mL
Geometric Coefficient of Variation 60.0
|
1402 ng/mL
Geometric Coefficient of Variation 56.1
|
1379 ng/mL
Geometric Coefficient of Variation 32.2
|
800 ng/mL
Geometric Coefficient of Variation 726
|
3251 ng/mL
Geometric Coefficient of Variation 37.8
|
497 ng/mL
|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
79.5 ng/mL
|
—
|
127 ng/mL
Geometric Coefficient of Variation 27.6
|
152 ng/mL
Geometric Coefficient of Variation 95.1
|
241 ng/mL
Geometric Coefficient of Variation 76.7
|
455 ng/mL
Geometric Coefficient of Variation 38.5
|
648 ng/mL
Geometric Coefficient of Variation 51.0
|
881 ng/mL
Geometric Coefficient of Variation 78.8
|
1055 ng/mL
Geometric Coefficient of Variation 45.9
|
1154 ng/mL
Geometric Coefficient of Variation 26.4
|
2097 ng/mL
Geometric Coefficient of Variation 21.1
|
4020 ng/mL
|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0170 ng/mL
Geometric Coefficient of Variation 46.9
|
0.132 ng/mL
Geometric Coefficient of Variation 413
|
0.0140 ng/mL
Geometric Coefficient of Variation 4.21
|
0.0270 ng/mL
|
0.0170 ng/mL
Geometric Coefficient of Variation 20.1
|
—
|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
61.5 ng/mL
|
—
|
151 ng/mL
Geometric Coefficient of Variation 23.2
|
208 ng/mL
Geometric Coefficient of Variation 18.4
|
164 ng/mL
|
424 ng/mL
Geometric Coefficient of Variation 47.8
|
808 ng/mL
Geometric Coefficient of Variation 55.8
|
1084 ng/mL
Geometric Coefficient of Variation 59.9
|
1084 ng/mL
Geometric Coefficient of Variation 32.0
|
645 ng/mL
Geometric Coefficient of Variation 655
|
2090 ng/mL
Geometric Coefficient of Variation 31.6
|
497 ng/mL
|
|
Maximum Observed Serum Concentration (Cmax) for Camidanlumab Tesirine
Cycle 1 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0120 ng/mL
Geometric Coefficient of Variation 8.04
|
0.0310 ng/mL
Geometric Coefficient of Variation 102
|
0.0150 ng/mL
Geometric Coefficient of Variation 34.6
|
0.0110 ng/mL
|
0.0170 ng/mL
|
0.0240 ng/mL
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Tmax for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=25 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
0.155 Days
|
—
|
0.114 Days
Geometric Coefficient of Variation 46.4
|
0.110 Days
Geometric Coefficient of Variation 24.6
|
0.131 Days
Geometric Coefficient of Variation 64.3
|
0.0910 Days
Geometric Coefficient of Variation 47.1
|
0.0950 Days
Geometric Coefficient of Variation 62.4
|
0.0970 Days
Geometric Coefficient of Variation 44.6
|
0.118 Days
Geometric Coefficient of Variation 83.0
|
0.111 Days
Geometric Coefficient of Variation 22.3
|
0.114 Days
Geometric Coefficient of Variation 46.7
|
0.0830 Days
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 1 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.119 Days
Geometric Coefficient of Variation 75.0
|
0.124 Days
Geometric Coefficient of Variation 83.6
|
0.206 Days
Geometric Coefficient of Variation 69.8
|
0.211 Days
|
0.240 Days
|
0.172 Days
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
0.155 Days
|
0.0830 Days
|
0.0970 Days
Geometric Coefficient of Variation 22.4
|
0.149 Days
Geometric Coefficient of Variation 75.3
|
0.103 Days
Geometric Coefficient of Variation 26.4
|
0.0820 Days
Geometric Coefficient of Variation 38.5
|
0.0950 Days
Geometric Coefficient of Variation 67.5
|
0.106 Days
Geometric Coefficient of Variation 58.3
|
0.105 Days
Geometric Coefficient of Variation 45.1
|
0.111 Days
Geometric Coefficient of Variation 22.3
|
0.157 Days
Geometric Coefficient of Variation 0.937
|
0.172 Days
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
0.149 Days
|
—
|
0.110 Days
Geometric Coefficient of Variation 32.2
|
0.137 Days
Geometric Coefficient of Variation 69.8
|
0.130 Days
|
0.0640 Days
Geometric Coefficient of Variation 105
|
0.0790 Days
Geometric Coefficient of Variation 81.6
|
0.0910 Days
Geometric Coefficient of Variation 100
|
0.0830 Days
Geometric Coefficient of Variation 71.7
|
0.0700 Days
Geometric Coefficient of Variation 31.4
|
0.145 Days
Geometric Coefficient of Variation 21.1
|
0.0310 Days
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
0.336 Days
|
—
|
0.126 Days
Geometric Coefficient of Variation 37.9
|
0.0860 Days
Geometric Coefficient of Variation 1.70
|
0.0920 Days
|
0.0640 Days
Geometric Coefficient of Variation 121
|
0.0660 Days
Geometric Coefficient of Variation 64.3
|
0.0690 Days
Geometric Coefficient of Variation 110
|
0.0720 Days
Geometric Coefficient of Variation 79.3
|
0.0850 Days
Geometric Coefficient of Variation 2.89
|
0.0940 Days
Geometric Coefficient of Variation 160
|
0.0310 Days
|
|
Time to Reach the Maximum Serum Concentration (Tmax) for Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.192 Days
Geometric Coefficient of Variation 42.6
|
0.0970 Days
Geometric Coefficient of Variation 119
|
0.201 Days
Geometric Coefficient of Variation 24.8
|
0.167 Days
|
0.156 Days
Geometric Coefficient of Variation 109
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
AUC0-last for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=25 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
21.0 day*ng/mL
|
—
|
111 day*ng/mL
Geometric Coefficient of Variation 35.0
|
453 day*ng/mL
Geometric Coefficient of Variation 35.3
|
473 day*ng/mL
|
1004 day*ng/mL
Geometric Coefficient of Variation 66.8
|
2476 day*ng/mL
Geometric Coefficient of Variation 117
|
3665 day*ng/mL
Geometric Coefficient of Variation 127
|
4190 day*ng/mL
Geometric Coefficient of Variation 123
|
921 day*ng/mL
Geometric Coefficient of Variation 1700356
|
12767 day*ng/mL
Geometric Coefficient of Variation 13.1
|
919 day*ng/mL
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
12.0 day*ng/mL
|
—
|
58.8 day*ng/mL
Geometric Coefficient of Variation 458
|
76.8 day*ng/mL
Geometric Coefficient of Variation 470
|
262 day*ng/mL
Geometric Coefficient of Variation 276
|
625 day*ng/mL
Geometric Coefficient of Variation 53.1
|
1173 day*ng/mL
Geometric Coefficient of Variation 113
|
1623 day*ng/mL
Geometric Coefficient of Variation 102
|
1630 day*ng/mL
Geometric Coefficient of Variation 155
|
2849 day*ng/mL
Geometric Coefficient of Variation 68.0
|
7727 day*ng/mL
Geometric Coefficient of Variation 11.2
|
18915 day*ng/mL
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
18.6 day*ng/mL
|
—
|
85.8 day*ng/mL
Geometric Coefficient of Variation 15.9
|
237 day*ng/mL
Geometric Coefficient of Variation 23.1
|
330 day*ng/mL
|
655 day*ng/mL
Geometric Coefficient of Variation 53.3
|
1514 day*ng/mL
Geometric Coefficient of Variation 103
|
2283 day*ng/mL
Geometric Coefficient of Variation 94.5
|
3038 day*ng/mL
Geometric Coefficient of Variation 97.7
|
1482 day*ng/mL
Geometric Coefficient of Variation 13082
|
8992 day*ng/mL
Geometric Coefficient of Variation 28.3
|
634 day*ng/mL
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
82.7 day*ng/mL
|
2.60 day*ng/mL
|
48.2 day*ng/mL
Geometric Coefficient of Variation 207
|
76.3 day*ng/mL
Geometric Coefficient of Variation 1444
|
660 day*ng/mL
Geometric Coefficient of Variation 93.7
|
967 day*ng/mL
Geometric Coefficient of Variation 60.4
|
1715 day*ng/mL
Geometric Coefficient of Variation 128
|
2491 day*ng/mL
Geometric Coefficient of Variation 132
|
2751 day*ng/mL
Geometric Coefficient of Variation 109
|
4091 day*ng/mL
Geometric Coefficient of Variation 84.6
|
12919 day*ng/mL
Geometric Coefficient of Variation 14.6
|
30759 day*ng/mL
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 1 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.00200 day*ng/mL
Geometric Coefficient of Variation 331
|
0.00200 day*ng/mL
Geometric Coefficient of Variation 127
|
0.00300 day*ng/mL
Geometric Coefficient of Variation 290
|
0.0100 day*ng/mL
|
0.00400 day*ng/mL
|
0.0360 day*ng/mL
|
|
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) for Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
0.00300 day*ng/mL
Geometric Coefficient of Variation 74.6
|
0.0330 day*ng/mL
Geometric Coefficient of Variation 183
|
0.00600 day*ng/mL
Geometric Coefficient of Variation 79.8
|
0.00300 day*ng/mL
|
0.0130 day*ng/mL
Geometric Coefficient of Variation 5.60
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
AUC0-tau for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199) for Cycle 2 only.
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=33 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=23 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=17 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0310 day*ng/mL
|
—
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
—
|
—
|
195 day*ng/mL
Geometric Coefficient of Variation 22.3
|
596 day*ng/mL
Geometric Coefficient of Variation 25.9
|
747 day*ng/mL
|
1384 day*ng/mL
Geometric Coefficient of Variation 62.6
|
3604 day*ng/mL
Geometric Coefficient of Variation 68.9
|
4688 day*ng/mL
Geometric Coefficient of Variation 98.3
|
5689 day*ng/mL
Geometric Coefficient of Variation 58.2
|
18830 day*ng/mL
|
17031 day*ng/mL
Geometric Coefficient of Variation 45.1
|
1074 day*ng/mL
|
|
Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-t) for Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
—
|
—
|
185 day*ng/mL
|
385 day*ng/mL
Geometric Coefficient of Variation 28.5
|
489 day*ng/mL
|
939 day*ng/mL
Geometric Coefficient of Variation 53.6
|
2183 day*ng/mL
Geometric Coefficient of Variation 61.6
|
2811 day*ng/mL
Geometric Coefficient of Variation 76.7
|
3469 day*ng/mL
Geometric Coefficient of Variation 91.3
|
1809 day*ng/mL
Geometric Coefficient of Variation 4154
|
9851 day*ng/mL
Geometric Coefficient of Variation 28.3
|
763 day*ng/mL
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycle 1 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
AUC∞ HuMax-TAC and PBD-conjugated HuMax-TAC for Cycle 1 only.
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=14 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=23 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
—
|
—
|
—
|
—
|
—
|
1283 day*ng/mL
Geometric Coefficient of Variation 63.1
|
3001 day*ng/mL
Geometric Coefficient of Variation 75.0
|
3618 day*ng/mL
Geometric Coefficient of Variation 52.9
|
3261 day*ng/mL
Geometric Coefficient of Variation 83.9
|
4972 day*ng/mL
Geometric Coefficient of Variation 116
|
13842 day*ng/mL
Geometric Coefficient of Variation 9.45
|
33153 day*ng/mL
|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
—
|
—
|
—
|
—
|
917 day*ng/mL
|
1019 day*ng/mL
Geometric Coefficient of Variation 54.9
|
1846 day*ng/mL
Geometric Coefficient of Variation 59.9
|
2284 day*ng/mL
Geometric Coefficient of Variation 50.8
|
2797 day*ng/mL
Geometric Coefficient of Variation 81.7
|
3734 day*ng/mL
Geometric Coefficient of Variation 82.7
|
8730 day*ng/mL
Geometric Coefficient of Variation 5.31
|
20144 day*ng/mL
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
AI for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (21 day cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=33 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=22 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=17 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Index (AI) for Camidanlumab Tesirine
HuMax-TAC
|
—
|
—
|
1.00 Ratio
Geometric Coefficient of Variation 0.0000132
|
1.00 Ratio
Geometric Coefficient of Variation 0.000584
|
1.00 Ratio
|
1.01 Ratio
Geometric Coefficient of Variation 3.41
|
1.02 Ratio
Geometric Coefficient of Variation 2.59
|
1.03 Ratio
Geometric Coefficient of Variation 4.24
|
1.04 Ratio
Geometric Coefficient of Variation 3.48
|
1.23 Ratio
|
1.08 Ratio
Geometric Coefficient of Variation 6.58
|
1.00 Ratio
|
|
Accumulation Index (AI) for Camidanlumab Tesirine
PBD-conjugated HuMax-TAC
|
—
|
—
|
1.00 Ratio
|
1.00 Ratio
Geometric Coefficient of Variation 0.00153
|
1.00 Ratio
|
1.00 Ratio
Geometric Coefficient of Variation 0.234
|
1.01 Ratio
Geometric Coefficient of Variation 1.48
|
1.03 Ratio
Geometric Coefficient of Variation 4.94
|
1.03 Ratio
Geometric Coefficient of Variation 2.38
|
1.06 Ratio
Geometric Coefficient of Variation 8.36
|
1.06 Ratio
Geometric Coefficient of Variation 0.381
|
1.00 Ratio
|
|
Accumulation Index (AI) for Camidanlumab Tesirine
Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.00 Ratio
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Volume of distribution for HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=33 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=23 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution for Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
—
|
—
|
5.89 Liters
|
3.56 Liters
Geometric Coefficient of Variation 14.7
|
8.39 Liters
|
4.81 Liters
Geometric Coefficient of Variation 53.0
|
4.91 Liters
Geometric Coefficient of Variation 29.9
|
5.10 Liters
Geometric Coefficient of Variation 30.2
|
5.89 Liters
Geometric Coefficient of Variation 25.7
|
14.5 Liters
Geometric Coefficient of Variation 257
|
7.55 Liters
Geometric Coefficient of Variation 8.86
|
2.90 Liters
|
|
Volume of Distribution for Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7246 Liters
|
—
|
|
Volume of Distribution for Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
—
|
—
|
—
|
—
|
—
|
3.93 Liters
Geometric Coefficient of Variation 43.2
|
4.57 Liters
Geometric Coefficient of Variation 26.9
|
4.55 Liters
Geometric Coefficient of Variation 27.0
|
4.28 Liters
Geometric Coefficient of Variation 159
|
6.11 Liters
Geometric Coefficient of Variation 8.73
|
7.01 Liters
Geometric Coefficient of Variation 46.4
|
4.84 Liters
|
|
Volume of Distribution for Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
—
|
—
|
3.71 Liters
Geometric Coefficient of Variation 70.3
|
3.26 Liters
Geometric Coefficient of Variation 19.9
|
7.72 Liters
|
4.28 Liters
Geometric Coefficient of Variation 60.1
|
4.54 Liters
Geometric Coefficient of Variation 36.0
|
4.64 Liters
Geometric Coefficient of Variation 26.5
|
5.23 Liters
Geometric Coefficient of Variation 24.8
|
5.55 Liters
|
6.13 Liters
Geometric Coefficient of Variation 6.58
|
2.44 Liters
|
|
Volume of Distribution for Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
—
|
—
|
—
|
—
|
2.23 Liters
|
3.28 Liters
Geometric Coefficient of Variation 56.7
|
5.08 Liters
Geometric Coefficient of Variation 23.3
|
5.05 Liters
Geometric Coefficient of Variation 25.5
|
5.15 Liters
Geometric Coefficient of Variation 34.5
|
6.91 Liters
Geometric Coefficient of Variation 14.4
|
9.03 Liters
Geometric Coefficient of Variation 71.7
|
5.84 Liters
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
T1/2 of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=33 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=23 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
—
|
—
|
—
|
—
|
1.75 Days
|
1.39 Days
Geometric Coefficient of Variation 49.8
|
2.31 Days
Geometric Coefficient of Variation 45.5
|
2.43 Days
Geometric Coefficient of Variation 44.7
|
2.11 Days
Geometric Coefficient of Variation 78.6
|
2.92 Days
Geometric Coefficient of Variation 152
|
5.59 Days
Geometric Coefficient of Variation 50.9
|
7.16 Days
|
|
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
—
|
—
|
1.30 Days
|
1.37 Days
Geometric Coefficient of Variation 5.69
|
2.24 Days
|
1.78 Days
Geometric Coefficient of Variation 28.4
|
2.69 Days
Geometric Coefficient of Variation 40.2
|
2.93 Days
Geometric Coefficient of Variation 62.2
|
3.06 Days
Geometric Coefficient of Variation 67.2
|
3.03 Days
Geometric Coefficient of Variation 156
|
5.02 Days
Geometric Coefficient of Variation 2.26
|
1.67 Days
|
|
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
—
|
—
|
—
|
—
|
—
|
1.58 Days
Geometric Coefficient of Variation 58.9
|
2.62 Days
Geometric Coefficient of Variation 44.1
|
2.76 Days
Geometric Coefficient of Variation 51.9
|
1.98 Days
Geometric Coefficient of Variation 78.1
|
2.49 Days
Geometric Coefficient of Variation 131
|
4.42 Days
Geometric Coefficient of Variation 0.622
|
7.68 Days
|
|
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
—
|
—
|
0.835 Days
Geometric Coefficient of Variation 16.9
|
1.63 Days
Geometric Coefficient of Variation 0.507
|
2.61 Days
|
1.87 Days
Geometric Coefficient of Variation 50.7
|
3.26 Days
Geometric Coefficient of Variation 38.0
|
3.26 Days
Geometric Coefficient of Variation 59.5
|
3.65 Days
Geometric Coefficient of Variation 42.4
|
8.74 Days
|
5.38 Days
Geometric Coefficient of Variation 34.4
|
1.43 Days
|
|
Apparent Terminal Half-life (T1/2) of Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.18 Days
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 and 1 to 336 hours post-dose of Cycles 1 and 2 (21 day cycle length)Population: Pharmacokinetic (PK) analysis set consisted of all participants who received study drug and have sufficient concentration data for PK analysis.
Clearance of HuMax-TAC, PBD-conjugated HuMax-TAC, and free warhead (SG3199).
Outcome measures
| Measure |
3 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=1 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=33 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=23 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=18 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance of Camidanlumab Tesirine
Cycle 1 - HuMax-TAC
|
—
|
—
|
—
|
—
|
—
|
1.82 Liters/day
Geometric Coefficient of Variation 69.0
|
1.29 Liters/day
Geometric Coefficient of Variation 64.0
|
1.24 Liters/day
Geometric Coefficient of Variation 54.5
|
1.60 Liters/day
Geometric Coefficient of Variation 184
|
1.82 Liters/day
Geometric Coefficient of Variation 136
|
1.05 Liters/day
Geometric Coefficient of Variation 22.6
|
0.489 Liters/day
|
|
Clearance of Camidanlumab Tesirine
Cycle 2 - HuMax-TAC
|
—
|
—
|
3.23 Liters/day
Geometric Coefficient of Variation 50.1
|
1.44 Liters/day
Geometric Coefficient of Variation 22.5
|
2.01 Liters/day
|
1.60 Liters/day
Geometric Coefficient of Variation 66.5
|
1.03 Liters/day
Geometric Coefficient of Variation 61.2
|
0.950 Liters/day
Geometric Coefficient of Variation 85.9
|
1.10 Liters/day
Geometric Coefficient of Variation 46.2
|
0.446 Liters/day
|
0.849 Liters/day
Geometric Coefficient of Variation 30.8
|
1.23 Liters/day
|
|
Clearance of Camidanlumab Tesirine
Cycle 1 - PBD-conjugated HuMax-TAC
|
—
|
—
|
—
|
—
|
0.943 Liters/day
|
1.75 Liters/day
Geometric Coefficient of Variation 55.6
|
1.68 Liters/day
Geometric Coefficient of Variation 50.3
|
1.65 Liters/day
Geometric Coefficient of Variation 48.9
|
1.87 Liters/day
Geometric Coefficient of Variation 99.0
|
1.94 Liters/day
Geometric Coefficient of Variation 98.7
|
1.33 Liters/day
Geometric Coefficient of Variation 18.4
|
0.643 Liters/day
|
|
Clearance of Camidanlumab Tesirine
Cycle 2 - PBD-conjugated HuMax-TAC
|
—
|
—
|
3.27 Liters/day
|
1.79 Liters/day
Geometric Coefficient of Variation 25.1
|
2.46 Liters/day
|
1.93 Liters/day
Geometric Coefficient of Variation 57.2
|
1.37 Liters/day
Geometric Coefficient of Variation 55.3
|
1.27 Liters/day
Geometric Coefficient of Variation 62.8
|
1.44 Liters/day
Geometric Coefficient of Variation 86.9
|
3.28 Liters/day
Geometric Coefficient of Variation 2602
|
1.17 Liters/day
Geometric Coefficient of Variation 15.0
|
1.38 Liters/day
|
|
Clearance of Camidanlumab Tesirine
Cycle 2 - Free warhead (SG3199)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4302 Liters/day
|
—
|
SECONDARY outcome
Timeframe: Day 1 to End of Study (a maximum of 12 months after last dose; median time on treatment was 43 days [min 1 day; max 354 days])Population: Safety Analysis Set - The safety analysis set consisted of all participants who received camidanlumab tesirine.
An assay determines the presence of anti-ADCT-301 antibodies in human serum using a validated bridging electro chemiluminescence immunoassay (ECLIA) technique. The technique uses the drug itself to capture any anti ADCT-301 antibodies present in the serum. If anti-ADCT-301 antibodies are detected, they are confirmed to be specifically against ADCT-301 and then the level of the anti-ADCT-301 antibodies present in the serum is established using a modified version of the ECLIA technique.
Outcome measures
| Measure |
3 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 Participants
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 Participants
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
Confirmed positive ADA pre-dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
Confirmed positive ADA post-dose only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibody Response (ADA) Against Camidanlumab Tesirine
Confirmed positive ADA at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3 μg/kg
5 μg/kg
8 μg/kg
13 μg/kg
20 μg/kg
30 μg/kg
45 μg/kg
60 μg/kg
80 μg/kg
100 μg/kg
150 μg/kg
300 μg/kg
Serious adverse events
| Measure |
3 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 participants at risk
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Number of events 4 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Number of events 3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
23.1%
6/26 • Number of events 7 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Disease progression
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Fatigue
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Chills
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Death
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Infusion site extravasation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 4 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkins disease
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Number of events 3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Number of events 4 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Number of events 4 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Number of events 5 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Number of events 2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Number of events 1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
Other adverse events
| Measure |
3 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (3 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
5 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (5 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 4 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
8 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (8 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
13 μg/kg
n=3 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (13 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 15 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
20 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (20 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 3 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
30 μg/kg
n=20 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (30 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
45 μg/kg
n=41 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (45 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 10 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
60 μg/kg
n=29 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (60 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 8 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
80 μg/kg
n=26 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (80 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 7 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
100 μg/kg
n=3 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (100 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 5 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
150 μg/kg
n=2 participants at risk
Participants received an intravenous (IV) infusion of camidanlumab tesirine (150 μg/kg) on Day 1 of each 3-week treatment cycle, for a maximum of 2 cycles.
Camidanlumab tesirine: Intravenous (IV) infusion.
|
300 μg/kg
n=1 participants at risk
A single participant received by error an intravenous (IV) infusion of camidanlumab tesirine (300 μg/kg) on Day 1 of Cycle 1 (planned dose was 30 μg/kg). Dosing in the subsequent cycles was 30 μg/kg (for 2 more cycles).
Camidanlumab tesirine: Intravenous (IV) infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
35.0%
7/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
39.0%
16/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
31.0%
9/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
22.0%
9/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
35.0%
7/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
12.2%
5/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.2%
5/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.2%
5/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
66.7%
2/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
30.0%
6/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.5%
8/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Diplopia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
40.0%
8/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.5%
8/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
24.1%
7/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
26.9%
7/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
25.0%
5/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
29.3%
12/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
26.8%
11/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
14.6%
6/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.2%
5/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.1%
7/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.2%
5/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Fatigue
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
10/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
39.0%
16/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
44.8%
13/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
26.9%
7/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
25.0%
5/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
26.8%
11/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
27.6%
8/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
30.8%
8/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
12.2%
5/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Face oedema
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Chills
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Localised oedema
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Asthenia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Chest pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Inflammation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Malaise
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.5%
8/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
27.6%
8/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
23.1%
6/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
22.0%
9/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.1%
7/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
23.1%
6/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
12.2%
5/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
66.7%
2/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
30.8%
8/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Lipase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
14.6%
6/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
12.2%
5/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.2%
5/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Amylase increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood albumin decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Weight increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Investigations
Blood uric acid increased
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.5%
8/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
66.7%
2/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
19.2%
5/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
25.0%
5/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.0%
4/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
12.2%
5/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.3%
3/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.3%
3/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
7.7%
2/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
4.9%
2/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
100.0%
1/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
25.0%
5/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
22.0%
9/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
26.9%
7/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
17.1%
7/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
20.7%
6/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.4%
4/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
10.0%
2/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
13.8%
4/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
33.3%
1/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
15.0%
3/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
11.5%
3/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
50.0%
1/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
9.8%
4/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.4%
1/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
3.8%
1/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
5.0%
1/20 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
2.4%
1/41 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
6.9%
2/29 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/26 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/3 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/2 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
0.00%
0/1 • Day 1 up to 84 days after last dose (median time on treatment was 43 days [min 1 day; max 354 days])
AEs and SAEs were collected from Day 1 to 84 days after last dose (median time on treatment was 43 days \[min 1 day; max 354 days\]). All cause mortality was collected from Day 1 to End of Study (maximum of 12 months after last dose; median time on treatment was 43 days \[min 1 day; max 354 days\]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI can publish after first multi-site publication or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on PI is sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period \>60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results
- Publication restrictions are in place
Restriction type: OTHER