Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors (NCT NCT02541604)
NCT ID: NCT02541604
Last Updated: 2020-02-25
Results Overview
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
Results posted on
2020-02-25
Participant Flow
Participant milestones
| Measure |
COHORT 1
EWING SARCOMA
|
COHORT 2
HODGKIN LYMPHOMA
|
COHORT 3
NEUROBLASTOMA
|
COHORT 4
NON HODGKIN LYMPHOMA
|
COHORT 5
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
|
COHORT 6
OSTEOSARCOMA
|
COHORT 7
RHABDOMYOSARCOMA
|
COHORT 8
WILMS TUMOR
|
COHORT 9
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
|
COHORT 10
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
|
COHORT 11
RHABDOID TUMOR
|
COHORT 12
ATYPICAL TERATOID RHABDOID TUMOR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
11
|
3
|
10
|
10
|
10
|
10
|
4
|
4
|
2
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
11
|
3
|
10
|
10
|
10
|
10
|
4
|
4
|
2
|
3
|
Reasons for withdrawal
| Measure |
COHORT 1
EWING SARCOMA
|
COHORT 2
HODGKIN LYMPHOMA
|
COHORT 3
NEUROBLASTOMA
|
COHORT 4
NON HODGKIN LYMPHOMA
|
COHORT 5
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
|
COHORT 6
OSTEOSARCOMA
|
COHORT 7
RHABDOMYOSARCOMA
|
COHORT 8
WILMS TUMOR
|
COHORT 9
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
|
COHORT 10
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
|
COHORT 11
RHABDOID TUMOR
|
COHORT 12
ATYPICAL TERATOID RHABDOID TUMOR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
6
|
5
|
7
|
2
|
9
|
8
|
9
|
9
|
3
|
4
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
4
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Medical condition may jeopardize safety
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors
Baseline characteristics by cohort
| Measure |
COHORT 1
n=11 Participants
EWING SARCOMA
|
COHORT 2
n=9 Participants
HODGKIN LYMPHOMA
|
COHORT 3
n=11 Participants
NEUROBLASTOMA
|
COHORT 4
n=3 Participants
NON HODGKIN LYMPHOMA
|
COHORT 5
n=10 Participants
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
|
COHORT 6
n=10 Participants
OSTEOSARCOMA
|
COHORT 7
n=10 Participants
RHABDOMYOSARCOMA
|
COHORT 8
n=10 Participants
WILMS TUMOR
|
COHORT 9
n=4 Participants
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
|
COHORT 10
n=4 Participants
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
|
COHORT 11
n=2 Participants
RHABDOID TUMOR
|
COHORT 12
n=3 Participants
ATYPICAL TERATOID RHABDOID TUMOR
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.6 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
14.2 Years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
12.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
19.0 Years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
14.5 Years
STANDARD_DEVIATION 6.5 • n=21 Participants
|
17.1 Years
STANDARD_DEVIATION 4.1 • n=8 Participants
|
13.0 Years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
12.6 Years
STANDARD_DEVIATION 6.8 • n=24 Participants
|
14.8 Years
STANDARD_DEVIATION 1.0 • n=42 Participants
|
11.3 Years
STANDARD_DEVIATION 0.5 • n=42 Participants
|
0.5 Years
STANDARD_DEVIATION 0.7 • n=42 Participants
|
7.3 Years
STANDARD_DEVIATION 4.6 • n=42 Participants
|
13.5 Years
STANDARD_DEVIATION 6.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
40 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
47 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
16 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
51 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
20 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
50 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
n=10 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=10 Participants
Participants with osteosarcoma.
|
Cohort 7
n=10 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
n=10 Participants
Participants with wilms tumor
|
Cohort 9
n=4 Participants
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
n=4 Participants
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
n=2 Participants
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors
|
0 Percentage
|
10.0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
—
|
PRIMARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma
|
0 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants with ewing sarcoma
|
Cohort 5
n=3 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
22.2 Percentage
|
33.3 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT)
|
0 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population (defined as patients who received any amount of study drug), in the Osteosarcoma cohort as per protocol. (Objective response for the other cohorts are measured with different response criteria, and these are described in Outcome Measures 1, 2, 3, and 4).
Outcome measures
| Measure |
Cohort 1
n=10 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma
|
0 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
n=10 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=10 Participants
Participants with osteosarcoma.
|
Cohort 7
n=10 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
n=10 Participants
Participants with wilms tumor
|
Cohort 9
n=4 Participants
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
n=4 Participants
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
n=2 Participants
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
|
1.2 Months
Interval 0.6 to 1.4
|
1.3 Months
Interval 1.1 to 1.4
|
1.2 Months
Interval 0.7 to 1.8
|
1.1 Months
Interval 0.8 to 1.3
|
1.3 Months
Interval 1.1 to 1.5
|
1.2 Months
Interval 0.7 to 1.3
|
1.2 Months
Interval 1.1 to 10.1
|
0.7 Months
Interval 0.3 to 1.1
|
—
|
PRIMARY outcome
Timeframe: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
|
2.6 Months
Interval 1.2 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants with ewing sarcoma
|
Cohort 5
n=3 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
2.8 Months
Interval 2.6 to 4.4
|
1.4 Months
Interval 1.1 to
More than 50% patient was censored.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT
|
1.4 Months
Interval 1.4 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline up to approximately 42 monthsPopulation: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=87 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Serious Adverse Events
|
37.9 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Adverse Events of Special Interest
|
44.8 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Adverse Events
|
97.7 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)Population: Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "\<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants with ewing sarcoma
|
Cohort 5
n=26 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=34 Participants
Participants with osteosarcoma.
|
Cohort 7
n=18 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Cycle 1
|
105 ug/mL
Geometric Coefficient of Variation 6.90
|
312 ug/mL
Geometric Coefficient of Variation 28.7
|
337 ug/mL
Geometric Coefficient of Variation 26.8
|
424 ug/mL
Geometric Coefficient of Variation 26.9
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Serum Concentration (Cmax) of Atezolizumab
Cycle 4
|
—
|
382 ug/mL
Geometric Coefficient of Variation 16.4
|
373 ug/mL
Geometric Coefficient of Variation 78.9
|
626 ug/mL
Geometric Coefficient of Variation 29.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)Population: Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "\<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
Outcome measures
| Measure |
Cohort 1
n=1 Participants
Participants with ewing sarcoma
|
Cohort 5
n=25 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=32 Participants
Participants with osteosarcoma.
|
Cohort 7
n=16 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 2
|
24.1 ug/mL
Geometric Coefficient of Variation NA
Later cycles are NA because 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
|
59.3 ug/mL
Geometric Coefficient of Variation 31.4
|
56.5 ug/mL
Geometric Coefficient of Variation 50.4
|
79.9 ug/mL
Geometric Coefficient of Variation 52.7
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 3
|
—
|
58.9 ug/mL
Geometric Coefficient of Variation 234.4
|
85.0 ug/mL
Geometric Coefficient of Variation 47.4
|
148 ug/mL
Geometric Coefficient of Variation 48.9
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 4
|
—
|
99.2 ug/mL
Geometric Coefficient of Variation 36.4
|
113 ug/mL
Geometric Coefficient of Variation 41.1
|
121 ug/mL
Geometric Coefficient of Variation 80.4
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Serum Concentration (Cmin) of Atezolizumab
Cycle 8
|
—
|
166 ug/mL
Geometric Coefficient of Variation 19.8
|
145 ug/mL
Geometric Coefficient of Variation 21.9
|
209 ug/mL
Geometric Coefficient of Variation 8.10
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)Population: Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.
Outcome measures
| Measure |
Cohort 1
n=17 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Atezolizumab Serum Concentration at Washout
|
1.91 ug/mL
Geometric Coefficient of Variation 2815.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)Population: Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants with ewing sarcoma
|
Cohort 5
n=29 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=38 Participants
Participants with osteosarcoma.
|
Cohort 7
n=18 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) of Atezolizumab
|
1130 ugxday/mL
Geometric Coefficient of Variation 5.28
|
2209 ugxday/mL
Geometric Coefficient of Variation 21.3
|
2816 ugxday/mL
Geometric Coefficient of Variation 17.7
|
3579 ugxday/mL
Geometric Coefficient of Variation 28.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)Population: The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.
Outcome measures
| Measure |
Cohort 1
n=78 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Baseline
|
2.6 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Post-baseline
|
14.3 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
Participants with ewing sarcoma
|
Cohort 5
n=1 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
|
—
|
13.2 Months
There was only 1 participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Participants with ewing sarcoma
|
Cohort 5
n=1 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
NA Months
Interval 4.1 to
Kaplan-Meier median estimate not reached.
|
NA Months
Kaplan-Meier median estimate not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had an objective response in this cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until death (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=87 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
7.4 Months
Interval 5.3 to 9.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
n=10 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=10 Participants
Participants with osteosarcoma.
|
Cohort 7
n=10 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
n=10 Participants
Participants with wilms tumor
|
Cohort 9
n=4 Participants
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
n=4 Participants
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
n=2 Participants
Participants with rhabdoid tumor.
|
Cohort 12
n=3 Participants
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
|
0 Percentage
|
10 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma
|
0 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants with ewing sarcoma
|
Cohort 5
n=3 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
33.3 Percentage
|
33.3 Percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
n=10 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
n=10 Participants
Participants with osteosarcoma.
|
Cohort 7
n=10 Participants
Participants with rhabdomyosarcoma
|
Cohort 8
n=10 Participants
Participants with wilms tumor
|
Cohort 9
n=4 Participants
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
n=4 Participants
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
n=2 Participants
Participants with rhabdoid tumor.
|
Cohort 12
n=3 Participants
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
|
1.3 Months
Interval 0.6 to 1.4
|
1.4 Months
Interval 1.3 to 3.7
|
1.2 Months
Interval 0.9 to 1.8
|
1.3 Months
Interval 1.1 to 1.8
|
1.4 Months
Interval 1.1 to 2.8
|
1.2 Months
Interval 0.7 to 1.3
|
1.2 Months
Interval 1.1 to 10.1
|
0.7 Months
Interval 0.3 to 1.1
|
6.9 Months
Interval 1.7 to 9.3
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma
|
6.9 Months
Interval 2.6 to 14.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
Participants with ewing sarcoma
|
Cohort 5
n=3 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
6.5 Months
Interval 2.6 to
More than 50% patient was censored.
|
3.7 Months
Interval 1.4 to
More than 50% patient was censored.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
Participants with ewing sarcoma
|
Cohort 5
n=1 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
|
—
|
13.2 Months
There was only 1 participant with response.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had response therefore no participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)Population: Included safety-evaluable population, defined as patients who received any amount of study drug.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Participants with ewing sarcoma
|
Cohort 5
n=1 Participants
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
|
NA Months
Interval 7.3 to
Kaplan-Meier median estimate not reached.
|
NA Months
Kaplan-Meier median estimate not reached.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to approximately 42 monthsAtezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Outcome measures
| Measure |
Cohort 1
n=69 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Optimal Dose of Atezolizumab in Pediatric Adult Participants
|
15 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline up to approximately 42 monthsAtezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Outcome measures
| Measure |
Cohort 1
n=18 Participants
Participants with ewing sarcoma
|
Cohort 5
Participants with non-rhabdomyosarcoma soft tissue sarcoma
|
Cohort 6
Participants with osteosarcoma.
|
Cohort 7
Participants with rhabdomyosarcoma
|
Cohort 8
Participants with wilms tumor
|
Cohort 9
Participants with other tumor types with documented PD-L1 expression.
|
Cohort 10
Participants with other tumor types without documented PD-L1 expression.
|
Cohort 11
Participants with rhabdoid tumor.
|
Cohort 12
Participants with atypical teratoid rhabdoid tumor.
|
|---|---|---|---|---|---|---|---|---|---|
|
Optimal Dose of Atezolizumab in Young Adult Participants
|
1200 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
COHORT 1
Serious events: 4 serious events
Other events: 11 other events
Deaths: 6 deaths
COHORT 2
Serious events: 3 serious events
Other events: 8 other events
Deaths: 5 deaths
COHORT 3
Serious events: 2 serious events
Other events: 11 other events
Deaths: 7 deaths
COHORT 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
COHORT 5
Serious events: 3 serious events
Other events: 10 other events
Deaths: 9 deaths
COHORT 6
Serious events: 6 serious events
Other events: 10 other events
Deaths: 8 deaths
COHORT 7
Serious events: 3 serious events
Other events: 10 other events
Deaths: 9 deaths
COHORT 8
Serious events: 5 serious events
Other events: 10 other events
Deaths: 9 deaths
COHORT 9
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
COHORT 10
Serious events: 3 serious events
Other events: 3 other events
Deaths: 4 deaths
COHORT 11
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
COHORT 12
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
COHORT 1
n=11 participants at risk
EWING SARCOMA
|
COHORT 2
n=9 participants at risk
HODGKIN LYMPHOMA
|
COHORT 3
n=11 participants at risk
NEUROBLASTOMA
|
COHORT 4
n=3 participants at risk
NON HODGKIN LYMPHOMA
|
COHORT 5
n=10 participants at risk
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
|
COHORT 6
n=10 participants at risk
OSTEOSARCOMA
|
COHORT 7
n=10 participants at risk
RHABDOMYOSARCOMA
|
COHORT 8
n=10 participants at risk
WILMS TUMOR
|
COHORT 9
n=4 participants at risk
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
|
COHORT 10
n=4 participants at risk
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
|
COHORT 11
n=2 participants at risk
RHABDOID TUMOR
|
COHORT 12
n=3 participants at risk
ATYPICAL TERATOID RHABDOID TUMOR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
LARGE INTESTINAL OBSTRUCTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
PANCREATITIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
CHEST PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
FATIGUE
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
PYREXIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
CHOLESTASIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
INCISION SITE ABSCESS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
1/2 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE HYPOTENSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
VITH NERVE DISORDER
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
SHOCK HAEMORRHAGIC
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
SUPERIOR VENA CAVA SYNDROME
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
Other adverse events
| Measure |
COHORT 1
n=11 participants at risk
EWING SARCOMA
|
COHORT 2
n=9 participants at risk
HODGKIN LYMPHOMA
|
COHORT 3
n=11 participants at risk
NEUROBLASTOMA
|
COHORT 4
n=3 participants at risk
NON HODGKIN LYMPHOMA
|
COHORT 5
n=10 participants at risk
NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA;
|
COHORT 6
n=10 participants at risk
OSTEOSARCOMA
|
COHORT 7
n=10 participants at risk
RHABDOMYOSARCOMA
|
COHORT 8
n=10 participants at risk
WILMS TUMOR
|
COHORT 9
n=4 participants at risk
OTHER TUMOR TYPES WITH DOCUMENTED PD-L1 EXPRESSION
|
COHORT 10
n=4 participants at risk
OTHER TUMOR TYPES WITHOUT DOCUMENTED PD-L1 EXPRESSION
|
COHORT 11
n=2 participants at risk
RHABDOID TUMOR
|
COHORT 12
n=3 participants at risk
ATYPICAL TERATOID RHABDOID TUMOR
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Congenital, familial and genetic disorders
FANCONI SYNDROME
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
ERYTHRODYSAESTHESIA SYNDROME
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Cardiac disorders
TACHYCARDIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
27.3%
3/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
27.3%
3/11 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
5/10 • Number of events 12 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
1/2 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
18.2%
2/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
THROMBOCYTOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Ear and labyrinth disorders
EAR PAIN
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
ECZEMA EYELIDS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
EYELID PTOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
OPSOCLONUS MYOCLONUS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
PHOTOPHOBIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
PHOTOPSIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
27.3%
3/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ANAL INCONTINENCE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
COLITIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
27.3%
3/11 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
60.0%
6/10 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
60.0%
6/10 • Number of events 7 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
60.0%
6/10 • Number of events 7 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
36.4%
4/11 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
LIP ULCERATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
36.4%
4/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 7 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
NONINFECTIVE GINGIVITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
RECTAL DISCHARGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
SUBILEUS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
VOMITING
|
27.3%
3/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
3/9 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
ASTHENIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
AXILLARY PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
CATHETER SITE ERYTHEMA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
CHEST PAIN
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
CHILLS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
FACE OEDEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
FATIGUE
|
18.2%
2/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
27.3%
3/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 13 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
60.0%
6/10 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
60.0%
6/10 • Number of events 7 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
GENERALISED OEDEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
MALAISE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
OEDEMA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
PAIN
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
PYREXIA
|
27.3%
3/11 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
3/9 • Number of events 9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
36.4%
4/11 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
66.7%
2/3 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
80.0%
8/10 • Number of events 14 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
5/10 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
THIRST
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
General disorders
VACCINATION SITE OEDEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
CANDIDA URETHRITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
DERMATOPHYTOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
GENITAL HERPES
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
HERPES VIRUS INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
LARYNGITIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
PARONYCHIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
44.4%
4/9 • Number of events 16 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
SKIN INFECTION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
STAPHYLOCOCCAL
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Infections and infestations
VULVITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
FALL
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
UROSTOMY COMPLICATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
27.3%
3/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
AMYLASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
ANTITHROMBIN III DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
36.4%
4/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD CHLORIDE DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD CREATININE INCREASED
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
BLOOD URINE PRESENT
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
CANDIDA TEST POSITIVE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
CARDIAC MURMUR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 6 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
NOROVIRUS TEST POSITIVE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
PLATELET COUNT DECREASED
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
PROTHROMBIN LEVEL DECREASED
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
VITAMIN K DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
9.1%
1/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
36.4%
4/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
40.0%
4/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
1/2 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
HAEMARTHROSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
18.2%
2/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR INFLAMMATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
AMPUTATION STUMP PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
HEADACHE
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 8 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
27.3%
3/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 8 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
30.0%
3/10 • Number of events 5 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
PHANTOM LIMB SYNDROME
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Product Issues
DEVICE BREAKAGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
ANXIETY
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
BRUXISM
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
GLYCOSURIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
CATARRH
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
27.3%
3/11 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
44.4%
4/9 • Number of events 14 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
5/10 • Number of events 8 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
1/2 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
IRREGULAR BREATHING
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
18.2%
2/11 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DISORDER OROPHARYNGEAL PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL INFLAMMATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
22.2%
2/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
BLISTER
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PERIORAL DERMATITIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PETECHIAE
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PITYRIASIS ROSEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLOURATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Surgical and medical procedures
CENTRAL VENOUS CATHETERISATION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
EMBOLISM
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
HOT FLUSH
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
HYPERMAGNESAEMIA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
33.3%
1/3 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
25.0%
1/4 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
20.0%
2/10 • Number of events 3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
50.0%
2/4 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Nervous system disorders
PARAPARESIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Psychiatric disorders
ABNORMAL BEHAVIOUR
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
URINARY RETENTION
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
11.1%
1/9 • Number of events 2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/11 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/9 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
9.1%
1/11 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
10.0%
1/10 • Number of events 1 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/10 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/4 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/2 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
0.00%
0/3 • From baseline up to approximately 42 months
Adverse Events reporting is for the Safety Evaluable Population, defined as patients who received any amount of any component of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER