Trial Outcomes & Findings for A Study of DS-2248 in Participants With Advanced Solid Tumors (NCT NCT01288430)
NCT ID: NCT01288430
Last Updated: 2021-10-05
Results Overview
Objective response rate was defined as the sum of complete response (CR) and partial response (PR) rates. CR was defined as a disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 months
Results posted on
2021-10-05
Participant Flow
A total of 60 participants who met all inclusion and no exclusion criteria were enrolled in the study.
Part 1: Dose escalation began with an accelerated titration design, with a starting dose of DS-2248 0.6 mg/m\^2 once daily. Part 2: Dose expansion was assessed in participants with Stage IIIB/IV non-small cell lung cancer with resistance to epidermal growth factor receptor tyrosine kinase inhibitor or ALK inhibitor therapy.
Participant milestones
| Measure |
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
2
|
3
|
5
|
7
|
3
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6
|
7
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0
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0
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0
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|
Part 1
COMPLETED
|
0
|
0
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0
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0
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0
|
0
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0
|
0
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0
|
0
|
|
Part 1
NOT COMPLETED
|
2
|
3
|
5
|
7
|
3
|
6
|
7
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0
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0
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0
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Part 2
STARTED
|
0
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0
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0
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0
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0
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0
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0
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12
|
12
|
3
|
|
Part 2
COMPLETED
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
|
12
|
12
|
3
|
Reasons for withdrawal
| Measure |
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1
Progressive disease
|
2
|
1
|
1
|
6
|
2
|
4
|
2
|
0
|
0
|
0
|
|
Part 1
Clinical disease progression
|
0
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Part 1
Death due to disease progression
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1
Adverse Event
|
0
|
0
|
3
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 1
Other
|
0
|
2
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 2
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
7
|
2
|
|
Part 2
Clinical disease progression
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
|
Part 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Part 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of DS-2248 in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Age, Continuous
|
75.0 years
STANDARD_DEVIATION 0.0 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
53.0 years
STANDARD_DEVIATION 17.4 • n=21 Participants
|
49.8 years
STANDARD_DEVIATION 11.6 • n=10 Participants
|
61.4 years
STANDARD_DEVIATION 12.9 • n=115 Participants
|
58.8 years
STANDARD_DEVIATION 11.2 • n=24 Participants
|
59.8 years
STANDARD_DEVIATION 11.8 • n=42 Participants
|
51.7 years
STANDARD_DEVIATION 2.5 • n=42 Participants
|
58.8 years
STANDARD_DEVIATION 12.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
31 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
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=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
7 participants
n=115 Participants
|
12 participants
n=24 Participants
|
12 participants
n=42 Participants
|
3 participants
n=42 Participants
|
60 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 monthsPopulation: Objective response rate was assessed in the Full Analysis Set.
Objective response rate was defined as the sum of complete response (CR) and partial response (PR) rates. CR was defined as a disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=2 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=4 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=10 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=5 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Objective Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 monthsPopulation: Best overall response was assessed in the Full Analysis Set.
Complete response (CR) was defined as a disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response rate (ORR) was defined as the sum of CR and PR rates.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=2 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=4 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=10 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=5 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Best Overall Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Confirmed CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Best Overall Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Confirmed PR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Best Overall Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Stable disease
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Summary of Best Overall Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Progressive disease
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Summary of Best Overall Response Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Non-evaluable
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 monthsPopulation: Disease control rate was assessed in the Full Analysis Set.
Disease control rate (DCR) was defined as the sum of complete response (CR) and partial response (PR) rates, and stable disease (SD) rate for a minimum of 12 weeks. Complete response (CR) was defined as a disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of diameters of target lesions), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=2 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=4 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=10 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=5 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Disease Control Rate Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 monthsPopulation: Duration of stable disease was assessed in participants in which data were available in the Full Analysis Set.
Duration of response measured from the time at which criteria were first met for complete (CR) or partial response (PR) until the first date that progressive disease (PD) was objectively documented. Participants who had not progressed at the data cut-off date were censored at their last evaluable tumor assessment date. Duration of stable disease (SD) measured from the date of enrollment until the first date that criteria for disease progression were met. The minimum time interval for the duration of SD was 6 weeks. Participants who had not progressed at the data cut-off date were censored at their last evaluable tumor assessment date.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=2 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=4 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=1 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=1 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=1 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Stable Disease Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
—
|
9.50 weeks
Interval 6.4 to 12.6
|
6.64 weeks
Interval 6.6 to 6.7
|
12.86 weeks
Interval 7.0 to 14.3
|
10.57 weeks
Interval 7.1 to 14.0
|
13.1 weeks
Interval 13.1 to 13.1
|
15.00 weeks
Interval 15.0 to 15.0
|
7.9 weeks
Interval 7.9 to 7.9
|
13.29 weeks
Interval 7.4 to 32.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, discontinuation of study, or death, up to 2 years 11 monthsPopulation: Progression-free survival was assessed in the Full Analysis Set.
Progression-free survival (PFS) defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of radiographic disease progression (as per RECIST V1.1) or death due to any cause. Participants who were alive with no objective documentation of (radiographic) disease progression by the data cut-off date were censored at the date of their last evaluable tumor assessment. Participants who were lost to follow-up or withdrew early from the study with no documented disease progression were censored at the last evaluable tumor assessment.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=2 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=4 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=10 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=2 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=5 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Progression-free Survival Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
5.64 weeks
Interval 4.0 to 7.3
|
6.00 weeks
Interval 5.0 to 12.6
|
6.57 weeks
Interval 6.4 to 6.7
|
7.21 weeks
Interval 7.0 to 14.3
|
7.14 weeks
Interval 5.6 to 14.0
|
10.00 weeks
Interval 6.9 to 13.1
|
10.93 weeks
Interval 6.9 to 15.0
|
5.71 weeks
Interval 5.1 to 7.9
|
13.29 weeks
Interval 7.4 to 32.7
|
7.00 weeks
Interval 5.6 to 8.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 predose, 0.5, 1, 2, 3, 4, 6, and 8 h postdose; Cycle 1, Day 2 and Day 15; Cycle 1, Day 8 predose, 1 and 6 h postdose; Cycle 2 and 3, Day 1, 8, and 15Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set for which data were available.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=1 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=3 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=1 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=1 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=1 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve From Zero to Infinity Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
356.01 ng*h/mL
|
675.57 ng*h/mL
Standard Deviation 478.25
|
837.50 ng*h/mL
Standard Deviation 606.70
|
501.21 ng*h/mL
Standard Deviation 161.80
|
645.62 ng*h/mL
Standard Deviation 257.30
|
459.96 ng*h/mL
|
76.47 ng*h/mL
|
122.56 ng*h/mL
Standard Deviation 60.78
|
186.16 ng*h/mL
Standard Deviation 102.20
|
362.31 ng*h/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 predose, 0.5, 1, 2, 3, 4, 6, and 8 h postdose; Cycle 1, Day 2 and Day 15; Cycle 1, Day 8 predose, 1 and 6 h postdose; Cycle 2 and 3, Day 1, 8, and 15Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set for which data were available.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Maximum Concentration Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
71.30 ng/mL
Standard Deviation 37.99
|
77.15 ng/mL
Standard Deviation 32.17
|
126.61 ng/mL
Standard Deviation 67.60
|
82.56 ng/mL
Standard Deviation 34.22
|
81.45 ng/mL
Standard Deviation 53.71
|
84.97 ng/mL
Standard Deviation 34.16
|
6.46 ng/mL
Standard Deviation 1.54
|
14.69 ng/mL
Standard Deviation 7.37
|
25.60 ng/mL
Standard Deviation 9.62
|
63.27 ng/mL
Standard Deviation 31.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 predose, 0.5, 1, 2, 3, 4, 6, and 8 h postdose; Cycle 1, Day 2 and Day 15; Cycle 1, Day 8 predose, 1 and 6 h postdose; Cycle 2 and 3, Day 1, 8, and 15Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set for which data were available.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Time at Maximum Concentration Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
1.2 hours
Standard Deviation 0.8
|
2.3 hours
Standard Deviation 1.0
|
2.1 hours
Standard Deviation 0.7
|
1.8 hours
Standard Deviation 0.9
|
1.6 hours
Standard Deviation 0.9
|
2.0 hours
Standard Deviation 1.1
|
2.0 hours
Standard Deviation 1.4
|
1.7 hours
Standard Deviation 0.6
|
1.1 hours
Standard Deviation 0.6
|
1.5 hours
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 predose, 0.5, 1, 2, 3, 4, 6, and 8 h postdose; Cycle 1, Day 2 and Day 15; Cycle 1, Day 8 predose, 1 and 6 h postdose; Cycle 2 and 3, Day 1, 8, and 15Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set for which data were available.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=1 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=3 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=1 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=1 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=1 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Terminal Half-life Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
8.57 hours
|
8.62 hours
Standard Deviation 1.21
|
10.05 hours
Standard Deviation 0.73
|
9.94 hours
Standard Deviation 0.93
|
9.23 hours
Standard Deviation 0.55
|
6.76 hours
|
9.58 hours
|
7.81 hours
Standard Deviation 1.75
|
8.11 hours
Standard Deviation 1.79
|
10.78 hours
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 predose, 0.5, 1, 2, 3, 4, 6, and 8 h postdose; Cycle 1, Day 2 and Day 15; Cycle 1, Day 8 predose, 1 and 6 h postdose; Cycle 2 and 3, Day 1, 8, and 15Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set for which data were available.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=1 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=3 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=9 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=5 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=1 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=1 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=1 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Pharmacokinetic Parameter Total Body Clearance Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
|
0.01 L/h
|
0.02 L/h
Standard Deviation 0.01
|
0.02 L/h
Standard Deviation 0.01
|
0.02 L/h
Standard Deviation 0.00
|
0.01 L/h
Standard Deviation 0.00
|
0.02 L/h
|
0.01 L/h
|
0.02 L/h
Standard Deviation 0.01
|
0.01 L/h
Standard Deviation 0.00
|
0.01 L/h
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 30 days post last dose, up to 2 years 11 monthsPopulation: Treatment-emergent adverse events were assessed in the Safety Analysis Set.
A treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous. A DS-2248-related TEAE is an TEAE that is related to DS-2248 in the relationship.
Outcome measures
| Measure |
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 Participants
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 Participants
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 Participants
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=33 Participants
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=12 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 Participants
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 Participants
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 Participants
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 Participants
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 Participants
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
Total - Part 2
n=27 Participants
All participants who received oral DS-2248 in Part 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Pruritus
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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2 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Weight increased
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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1 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Vision blurred
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Metabolism and Nutrition Disorders
|
0 Participants
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2 Participants
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2 Participants
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8 Participants
|
3 Participants
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1 Participants
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1 Participants
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0 Participants
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1 Participants
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2 Participants
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2 Participants
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6 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Drug-related TEAEs
|
1 Participants
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4 Participants
|
6 Participants
|
21 Participants
|
7 Participants
|
9 Participants
|
1 Participants
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0 Participants
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4 Participants
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5 Participants
|
2 Participants
|
18 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood and Lymphatic Disorders
|
0 Participants
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0 Participants
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0 Participants
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2 Participants
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3 Participants
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1 Participants
|
0 Participants
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0 Participants
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1 Participants
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1 Participants
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0 Participants
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4 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Anaemia
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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3 Participants
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1 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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4 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Thrombocytopenia
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Lymphopenia
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Cardiac Disorders
|
0 Participants
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0 Participants
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1 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Tachycardia
|
0 Participants
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0 Participants
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1 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Eye Disorders
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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3 Participants
|
2 Participants
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
|
5 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Retinal haemorrhage
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dry eye
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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2 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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2 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Photopsia
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Paraesthesia oral
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Gastrointestinal Disorders
|
1 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Abdominal distension
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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1 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Anorectal discomfort
|
1 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Constipation
|
0 Participants
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1 Participants
|
1 Participants
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2 Participants
|
1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Diarrhoea
|
1 Participants
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0 Participants
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0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
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0 Participants
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0 Participants
|
4 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dyspepsia
|
0 Participants
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0 Participants
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1 Participants
|
1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Flatulence
|
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Nausea
|
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0 Participants
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1 Participants
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1 Participants
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1 Participants
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2 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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4 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Vomiting
|
0 Participants
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0 Participants
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1 Participants
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3 Participants
|
0 Participants
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1 Participants
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0 Participants
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0 Participants
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1 Participants
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1 Participants
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1 Participants
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2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Abdominal pain
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Gastrooesophageal reflux disease
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Renal and Urinary Disorders
|
0 Participants
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0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
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0 Participants
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0 Participants
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0 Participants
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|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
General Disorders & Administration Site Conditions
|
0 Participants
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2 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Fatigue
|
0 Participants
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2 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Oedema peripheral
|
0 Participants
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0 Participants
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0 Participants
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1 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
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0 Participants
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0 Participants
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0 Participants
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|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Irritability
|
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
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Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Immune System Disorders
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hypersensitivity
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Investigations
|
1 Participants
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2 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Alanine aminotransferase increase
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
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0 Participants
|
1 Participants
|
0 Participants
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0 Participants
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1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Aspartate aminotransferase increased
|
0 Participants
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1 Participants
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1 Participants
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3 Participants
|
0 Participants
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0 Participants
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0 Participants
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0 Participants
|
1 Participants
|
0 Participants
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0 Participants
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0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood alkaline phosphatase increased
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
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0 Participants
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0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood creatinine increased
|
0 Participants
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0 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood urea increased
|
0 Participants
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0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood uric acid increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Blood phosphorus increased
|
0 Participants
|
0 Participants
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0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Weight decreased
|
0 Participants
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0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Vitreous floaters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Decreased appetite
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dehydration
|
0 Participants
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0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hyperglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hyperphosphataemia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hyperuricaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hypokalaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Musculoskeletal and Connective Tissue Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Renal failure acute
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Muscular weakness
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Musculoskeletal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Nervous System Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dysgeusia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Respiratory, Thoracic, and Mediastinal Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dyspnoea
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Reproductive System and Breast Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Breast tenderness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Skin and Subcutaneous Tissue Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Dry skin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Hyperhidrosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Onychoclasis
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Nystagmus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Drug Related Treatment Emergent Adverse Events Following Oral Administration of DS-2248 in Participants With Advanced Solid Tumors
Restless legs syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 participants at risk
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 participants at risk
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 participants at risk
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 participants at risk
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 participants at risk
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 participants at risk
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 participants at risk
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=12 participants at risk
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 participants at risk
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 participants at risk
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
General disorders
Device occlusion
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
Other adverse events
| Measure |
Part 1, Cohort 1: DS-2248 0.6 mg/m^2
n=2 participants at risk
Participants who received oral DS-2248 0.6 mg/m\^2 once daily.
|
Part 1, Cohort 2: DS-2248 1.2 mg/m^2
n=3 participants at risk
Participants who received oral DS-2248 1.2 mg/m\^2 once daily.
|
Part 1, Cohort 3: DS-2248 1.8 mg/m^2
n=5 participants at risk
Participants who received oral DS-2248 1.8 mg/m\^2 once daily.
|
Part 1, Cohort 4: DS-2248 2.7 mg/m^2
n=7 participants at risk
Participants who received oral DS-2248 2.7 mg/m\^2 once daily.
|
Part 1, Cohort 5: DS-2248 3.5 mg/m^2
n=3 participants at risk
Participants who received oral DS-2248 3.5 mg/m\^2 once daily.
|
Part 1, Cohort 6: DS-2248 4.5 mg/m^2
n=6 participants at risk
Participants who received oral DS-2248 4.5 mg/m\^2 once daily.
|
Part 1, Cohort 7: DS-2248 5.85 mg/m^2
n=7 participants at risk
Participants who received oral DS-2248 5.85 mg/m\^2 once daily.
|
Part 2, EGFR TKI-resistant: DS-2248 4.5 mg/m^2
n=12 participants at risk
Participants who were epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)-resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-resistant: DS-2248 4.5 mg/m^2
n=12 participants at risk
Participants who were ALK-inhibitor resistant and received oral 4.5 mg/m\^2 once daily.
|
Part 2, ALK-naive: DS-2248 4.5 mg/m^2
n=3 participants at risk
Participants who were ALK treatment naive and received oral 4.5 mg/m\^2 once daily.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
4/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
4/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
41.7%
5/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
25.0%
3/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
25.0%
3/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
60.0%
3/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
57.1%
4/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
4/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
57.1%
4/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
41.7%
5/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
25.0%
3/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
General disorders
Pyrexia
|
100.0%
2/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
50.0%
3/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
57.1%
4/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Investigations
Blood urea increased
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
40.0%
2/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
42.9%
3/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
16.7%
2/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
8.3%
1/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
66.7%
2/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
1/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
33.3%
2/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
20.0%
1/5 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/12 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
0.00%
0/3 • Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days post last dose, up to 2 years 11 months.
A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-treatment state, when the AE is continuous.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place