Trial Outcomes & Findings for QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors (NCT NCT00819169)
NCT ID: NCT00819169
Last Updated: 2024-08-20
Results Overview
Incidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Time from first dose up to 24 months
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
Part 1 Cohort 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
15
|
8
|
16
|
16
|
9
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
12
|
8
|
16
|
16
|
9
|
13
|
Reasons for withdrawal
| Measure |
Part 1 Cohort 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
1
|
1
|
1
|
5
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
1
|
0
|
6
|
2
|
2
|
1
|
|
Overall Study
Death
|
1
|
1
|
3
|
8
|
5
|
7
|
9
|
4
|
7
|
|
Overall Study
Ineligibility determined
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Administrative Decision
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
2
|
0
|
Baseline Characteristics
Part 1 and Part 2 were analyzed separately.
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=15 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=8 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
|
Part 2 Cohort 3
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
|
Part 2 Cohort 4
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Part 1
|
48.0 years
STANDARD_DEVIATION 20.9 • n=3 Participants • Part 1 and Part 2 were analyzed separately.
|
65.3 years
STANDARD_DEVIATION 1.2 • n=3 Participants • Part 1 and Part 2 were analyzed separately.
|
46.0 years
STANDARD_DEVIATION 4.4 • n=3 Participants • Part 1 and Part 2 were analyzed separately.
|
—
|
—
|
—
|
—
|
—
|
—
|
53.1 years
STANDARD_DEVIATION 14.1 • n=9 Participants • Part 1 and Part 2 were analyzed separately.
|
|
Age, Continuous
Part 2
|
—
|
—
|
—
|
61.0 years
STANDARD_DEVIATION 10.3 • n=15 Participants • Part 1 and Part 2 were analyzed separately.
|
67.0 years
STANDARD_DEVIATION 7.3 • n=8 Participants • Part 1 and Part 2 were analyzed separately.
|
59.1 years
STANDARD_DEVIATION 11.0 • n=16 Participants • Part 1 and Part 2 were analyzed separately.
|
60.2 years
STANDARD_DEVIATION 8.8 • n=16 Participants • Part 1 and Part 2 were analyzed separately.
|
58.0 years
STANDARD_DEVIATION 15.8 • n=9 Participants • Part 1 and Part 2 were analyzed separately.
|
51.3 years
STANDARD_DEVIATION 9.8 • n=16 Participants • Part 1 and Part 2 were analyzed separately.
|
58.8 years
STANDARD_DEVIATION 11.1 • n=80 Participants • Part 1 and Part 2 were analyzed separately.
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
2 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
8 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
2 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
9 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
10 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
44 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
2 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
7 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
11 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
11 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
43 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
2 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
2 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
3 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
6 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
White
|
2 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
3 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
3 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
12 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
5 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
13 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
13 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
8 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
14 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
73 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=3 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=7 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=16 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
0 Participants
n=9 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
1 Participants
n=15 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
3 Participants
n=87 Participants • For part 2 the full analysis population was used which included only those subjects that received investigational product.
|
PRIMARY outcome
Timeframe: Time from first dose up to 24 monthsIncidence of adverse events and clinical laboratory abnormalities defined as DLTs. Dose-limiting toxicities included any grade 3 or higher hematologic or nonhematologic toxicity related to conatumumab or the combination of conatumumab with ganitumab except for lymphocytopenia and anemia.
Outcome measures
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Time from first dose up to 24 monthsPopulation: A subject was included in the analysis if they received at least one dose of study drug.
The objective response rate (ORR) is defined as confirmed complete response or partial response using modified Response Evaluation Criteria in Solid Tumors \[RECIST\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=15 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=15 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from first dose up to 24 monthsProgression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=15 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=8 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=16 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
1.4 months
Interval 1.1 to 15.4
|
4.9 months
Interval 1.6 to 5.5
|
1.3 months
Interval 1.1 to 2.4
|
1.6 months
Interval 1.3 to 3.7
|
3.3 months
Interval 1.9 to 5.4
|
1.5 months
Interval 1.3 to 2.6
|
1.4 months
Interval 1.2 to 2.3
|
2.8 months
Interval 1.6 to 3.9
|
1.3 months
Interval 1.2 to 1.7
|
SECONDARY outcome
Timeframe: Time from first dose up to 24 monthsPopulation: Antibody Population = All subjects in the full analysis set tested for antibodies during the study.
Outcome measures
| Measure |
Part 1 Cohort 1
n=1 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=2 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=1 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=11 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=5 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
n=13 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=10 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
AMG 655 - Binding antibody positive at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
AMG 655 - Neutralizing antibody positive at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
AMG 479 - Binding antibody positive at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
To Evaluate Anti-AMG 655 Antibody Formation and Anti-AMG 479 Antibody Formation
AMG 479 - Neutralizing antibody positive at any time
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)Population: PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
Median, minimum, and maximum concentration of AMG 655 at specified time points.
Outcome measures
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=2 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=2 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=13 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
n=14 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
n=14 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=13 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Concentration Level of AMG 655
Cycle 1-End of Infusion
|
17.5 μg/mL
Interval 17.3 to 19.4
|
59.0 μg/mL
Interval 59.0 to 59.0
|
313 μg/mL
Interval 261.0 to 365.0
|
244 μg/mL
Interval 240.0 to 247.0
|
266 μg/mL
Interval 266.0 to 266.0
|
240 μg/mL
Interval 115.0 to 319.0
|
224 μg/mL
Interval 130.0 to 293.0
|
327 μg/mL
Interval 275.0 to 341.0
|
247 μg/mL
Interval 91.3 to 392.0
|
|
To Evaluate the Concentration Level of AMG 655
Cycle 3-End of infusion
|
23.6 μg/mL
Interval 23.6 to 23.6
|
62.3 μg/mL
Interval 62.3 to 62.3
|
302 μg/mL
Interval 302.0 to 302.0
|
448 μg/mL
Interval 448.0 to 448.0
|
—
|
311 μg/mL
Interval 233.0 to 380.0
|
253 μg/mL
Interval 253.0 to 253.0
|
423 μg/mL
Interval 356.0 to 490.0
|
371 μg/mL
Interval 328.0 to 466.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)Population: PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
Median, minimum, and maximum concentration of AMG 479 at specified time points.
Outcome measures
| Measure |
Part 1 Cohort 1
n=3 Participants
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=2 Participants
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=2 Participants
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=13 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=7 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
|
Part 2 Cohort 3
n=14 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
|
Part 2 Cohort 4
n=14 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=13 Participants
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
To Evaluate the Concentration Level of AMG 479
Cycle 3-End of Infusion
|
308 μg/mL
Interval 308.0 to 308.0
|
—
|
338 μg/mL
Interval 338.0 to 338.0
|
404 μg/mL
Interval 404.0 to 404.0
|
—
|
262 μg/mL
Interval 205.0 to 364.0
|
249 μg/mL
Interval 249.0 to 249.0
|
323 μg/mL
Interval 300.0 to 381.0
|
365 μg/mL
Interval 244.0 to 420.0
|
|
To Evaluate the Concentration Level of AMG 479
Cycle 1-End of infusion
|
272 μg/mL
Interval 198.0 to 279.0
|
268 μg/mL
Interval 268.0 to 268.0
|
303 μg/mL
Interval 257.0 to 349.0
|
215 μg/mL
Interval 193.0 to 237.0
|
297 μg/mL
Interval 297.0 to 297.0
|
227 μg/mL
Interval 130.0 to 634.0
|
236 μg/mL
Interval 121.0 to 391.0
|
324 μg/mL
Interval 248.0 to 439.0
|
254 μg/mL
Interval 169.0 to 445.0
|
SECONDARY outcome
Timeframe: Time from first dose up to 24 monthsPopulation: Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analyses of time to response was not calculated.
Time to response is the time from study day 1 to the first observation of an objective response. Subjects without an objective response are excluded from the analysis of this endpoint. Objective response is defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors (RECIST) and will be determined based on the Investigator-reported assessment only for subjects with measurable disease at baseline. Per RECIST v 1.1: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from objective response to 24 monthsPopulation: Because no subjects in Part 2, and only one subject in Part 1, had an objective response the analysis of duration of response was not calculated.
Duration of response is defined as the number of days between the date of first objective response to the time of the first progressive disease (per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] or clinical progression, whichever occurs first) or death due to any cause. Objective response is defined as a tumor response assessment of either complete response or partial response per modified RECIST where a complete response is the disappearance of all target lesions and a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Per RECIST v 1.1, disease progression is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Outcome measures
Outcome data not reported
Adverse Events
Part 1 Cohort 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1 Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1 Cohort 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Part 2 Cohort 1
Serious events: 3 serious events
Other events: 15 other events
Deaths: 8 deaths
Part 2 Cohort 2
Serious events: 6 serious events
Other events: 7 other events
Deaths: 5 deaths
Part 2 Cohort 3
Serious events: 2 serious events
Other events: 15 other events
Deaths: 7 deaths
Part 2 Cohort 4
Serious events: 3 serious events
Other events: 14 other events
Deaths: 9 deaths
Part 2 Cohort 5
Serious events: 3 serious events
Other events: 9 other events
Deaths: 4 deaths
Part 2 Cohort 6
Serious events: 2 serious events
Other events: 11 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Part 1 Cohort 1
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=15 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=7 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
|
Part 2 Cohort 3
n=16 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
|
Part 2 Cohort 4
n=16 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=15 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Small Intestine
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Asthenia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Bilirubin
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
28.6%
2/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
Other adverse events
| Measure |
Part 1 Cohort 1
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 2
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 1 Cohort 3
n=3 participants at risk
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
|
Part 2 Cohort 1
n=15 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
|
Part 2 Cohort 2
n=7 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous NSCLC
|
Part 2 Cohort 3
n=16 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) CRC
|
Part 2 Cohort 4
n=16 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
|
Part 2 Cohort 5
n=9 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
|
Part 2 Cohort 6
n=15 participants at risk
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Cardiac disorders
Pericardial Effusion
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Cardiac disorders
Sinus Tachycardia
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Distension
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
3/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
26.7%
4/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
31.2%
5/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
55.6%
5/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
20.0%
3/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Asthenia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
31.2%
5/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
18.8%
3/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Fatigue
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
46.7%
7/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
28.6%
2/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
56.2%
9/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
66.7%
6/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
20.0%
3/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Oedema Peripheral
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Pain
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Immune system disorders
Drug Hypersensitivity
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Fungal Skin Infection
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Oral Herpes
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
3/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Alanine Aminotransferase Abnormal
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Alanine Aminotransferase Increased
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Aspartate Aminotransferase Abnormal
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Alkaline Phosphatase Abnormal
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Glucose Increased
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Pressure Increased
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Ejection Fraction Decreased
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
46.7%
7/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
28.6%
2/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
43.8%
7/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
3/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
44.4%
4/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
28.6%
2/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
26.7%
4/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Small Intestine
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Ketonuria
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Oliguria
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
20.0%
3/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
3/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
44.4%
4/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Swelling Face
|
33.3%
1/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Eye disorders
Eye Discharge
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
13.3%
2/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Chest Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
33.3%
3/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Chills
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
40.0%
6/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
43.8%
7/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
25.0%
4/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
20.0%
3/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Early Satiety
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Facial Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Influenza Like Illness
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Injection Site Reaction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Mucous Membrane Disorder
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Oedema
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
12.5%
2/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
18.8%
3/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
26.7%
4/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
General disorders
Vessel Puncture Site Reaction
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Abscess
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Infections and infestations
Wound Infection
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Alanine Aminotransferase
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
28.6%
2/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Aspartate Aminotransferase
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Alkaline Phosphatase Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Amylase
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Amylase Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Blood Bilirubin
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Glycosylated Haemoglobin Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Haemoglobin
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Heart Rate Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Lipase Increased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
20.0%
3/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Metabolism and nutrition disorders
Weight Fluctuation
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Discomfort
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Progression
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
14.3%
1/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Respiratory, thoracic and mediastinal disorders
Hyperhidrosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
22.2%
2/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Hot Flush
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.7%
1/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
6.2%
1/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/3 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/7 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/16 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
11.1%
1/9 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
0.00%
0/15 • All serious adverse events that occurred after the subject signed the informed consent form through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months. All non-serious adverse events that occurred after enrollment through to the Day 30 Safety Follow-up Visit or 30 days after the last dose of protocol-specified therapy, whichever was later, up to 25 months.
Mortality was measured on all subjects. Adverse events were measured on the safety populations (All subjects who received at least one dose of study drug)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place