Trial Outcomes & Findings for Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD) (NCT NCT03226678)
NCT ID: NCT03226678
Last Updated: 2024-12-12
Results Overview
TEAEs were defined as adverse events (AEs) that occurred after dosing on Day 1 and up to 56 days after the last dose of study drug. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of probably, possibly, unlikely, or unrelated. A serious adverse event (SAE) is defined as any AE that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; was a congenital anomaly or birth defect. TEAEs were graded according to Common Terminology Criteria for Adverse Events v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Part A:From first dose of study drug (Part A Day 1) up to 30days after last dose of study drug in Part A,approximately 366days Part B:From first dose of study drug (Part B Day 1) up to 56days after last dose of study drug in Part B,approximately 980days
Results posted on
2024-12-12
Participant Flow
This Phase 2, prospective pilot study was conducted at 12 sites in Brazil and United States of America in subjects with primary diagnosis of warm antibody autoimmune hemolytic anemia (wAIHA) or cold agglutinin disease (CAD) in parallel between 27 March 2018 and 12 September 2022.
The study consisted of 2 parts: Part A (core study phase; 12 months) and Part B (long-term extension phase; until the subject discontinued or the development program was terminated). Subjects were screened within 30 days prior to the start of dosing on day 1. A total of 24 subjects were enrolled.
Participant milestones
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
Subjects diagnosed with wAIHA received pegcetacoplan 270 milligram (mg) per day subcutaneous (SC) infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Part A (Core Study Phase)
STARTED
|
5
|
6
|
7
|
6
|
0
|
0
|
|
Part A (Core Study Phase)
COMPLETED
|
3
|
3
|
5
|
5
|
0
|
0
|
|
Part A (Core Study Phase)
NOT COMPLETED
|
2
|
3
|
2
|
1
|
0
|
0
|
|
Part B (Long-Term Extension Phase)
STARTED
|
0
|
0
|
0
|
0
|
5
|
9
|
|
Part B (Long-Term Extension Phase)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Long-Term Extension Phase)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
9
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
Subjects diagnosed with wAIHA received pegcetacoplan 270 milligram (mg) per day subcutaneous (SC) infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Part A (Core Study Phase)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A (Core Study Phase)
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part A (Core Study Phase)
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A (Core Study Phase)
Non-compliance with study drug
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part A (Core Study Phase)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part A (Core Study Phase)
Withdrew, per Investigator
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Part B (Long-Term Extension Phase)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Part B (Long-Term Extension Phase)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part B (Long-Term Extension Phase)
Non-Compliance With Study Drug
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part B (Long-Term Extension Phase)
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
3
|
5
|
|
Part B (Long-Term Extension Phase)
Withdrew, Per Sponsor
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 17.57 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 22.12 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
75.7 years
STANDARD_DEVIATION 7.53 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 16.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic Or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Part A:From first dose of study drug (Part A Day 1) up to 30days after last dose of study drug in Part A,approximately 366days Part B:From first dose of study drug (Part B Day 1) up to 56days after last dose of study drug in Part B,approximately 980daysPopulation: The Safety set included all subjects who received at least 1 dose of study drug.
TEAEs were defined as adverse events (AEs) that occurred after dosing on Day 1 and up to 56 days after the last dose of study drug. A treatment-related TEAE is defined as a TEAE with a relationship to study drug of probably, possibly, unlikely, or unrelated. A serious adverse event (SAE) is defined as any AE that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant incapacity or substantial disruption of ability to conduct normal life functions; was a congenital anomaly or birth defect. TEAEs were graded according to Common Terminology Criteria for Adverse Events v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=5 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=9 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs with life threatening intensity
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
All TEAEs
|
5 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
Treatment related TEAEs
|
4 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
Serious AEs
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs leading to study drug discontinuation
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs leading to death
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs with mild intensity
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs with moderate intensity
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Including by Severity
TEAEs with severe intensity
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The intent-to-treat (ITT) analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
Hematology assessments of hemoglobin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in hemoglobin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=4 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin at Weeks 48 and 132
Week 48
|
0.38 gram per deciliter (g/dL)
Standard Deviation 2.347
|
1.93 gram per deciliter (g/dL)
Standard Deviation 0.874
|
1.62 gram per deciliter (g/dL)
Standard Deviation 1.522
|
2.63 gram per deciliter (g/dL)
Standard Deviation 1.694
|
—
|
—
|
|
Mean Change From Baseline in Hemoglobin at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
0.18 gram per deciliter (g/dL)
Standard Deviation 0.626
|
-0.20 gram per deciliter (g/dL)
Standard Deviation 2.029
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug.
The number of on-study RBC transfusions were monitored throughout the treatment period.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=5 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=9 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Number of Subjects Who Received Red Blood Cell (RBC) Transfusions
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
Hematology assessments of ARC were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in ARC results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=4 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Absolute Reticulocyte Count (ARC) at Weeks 48 and 132
Week 48
|
-145.050 10^9 cells/liter (L)
Standard Deviation 90.4181
|
-130.187 10^9 cells/liter (L)
Standard Deviation 70.4638
|
-73.515 10^9 cells/liter (L)
Standard Deviation 73.1983
|
-84.064 10^9 cells/liter (L)
Standard Deviation 46.0655
|
—
|
—
|
|
Mean Change From Baseline in Absolute Reticulocyte Count (ARC) at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
11.485 10^9 cells/liter (L)
Standard Deviation 4.9787
|
81.585 10^9 cells/liter (L)
Standard Deviation 83.4790
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
Serum chemistry assessments of LDH were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in LDH results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 48 and 132
Week 48
|
-51.8 international units/L
Standard Deviation 39.08
|
-169.7 international units/L
Standard Deviation 212.89
|
-475.8 international units/L
Standard Deviation 842.43
|
-77.8 international units/L
Standard Deviation 73.30
|
—
|
—
|
|
Mean Change From Baseline in Lactate Dehydrogenase (LDH) at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
1.78 international units/L
Standard Deviation 46.357
|
35.18 international units/L
Standard Deviation 82.727
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
Serum chemistry assessments of haptoglobin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in haptoglobin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Haptoglobin at Weeks 48 and 132
Week 48
|
0.715 g/L
Standard Deviation 0.7622
|
0.747 g/L
Standard Deviation 0.7306
|
0.528 g/L
Standard Deviation 0.4961
|
0.172 g/L
Standard Deviation 0.3404
|
—
|
—
|
|
Mean Change From Baseline in Haptoglobin at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
-0.270 g/L
Standard Deviation 0.6364
|
-0.335 g/L
Standard Deviation 0.1323
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
Serum chemistry assessments of indirect bilirubin were made at the last measurement prior to the first dose of pegcetacoplan (baseline) and periodically throughout the different parts of the treatment period. Mean change from baseline in indirect bilirubin results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=5 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Indirect Bilirubin at Weeks 48 and 132
Week 48
|
-10.723 micromole/L
Standard Deviation 4.2167
|
-9.697 micromole/L
Standard Deviation 5.2220
|
-15.879 micromole/L
Standard Deviation 15.1038
|
-17.981 micromole/L
Standard Deviation 7.0978
|
—
|
—
|
|
Mean Change From Baseline in Indirect Bilirubin at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
0.195 micromole/L
Standard Deviation 0.2764
|
4.095 micromole/L
Standard Deviation 8.7678
|
SECONDARY outcome
Timeframe: Pre-dose and 4 hours postdose on Day 1; pre-dose on Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120 and 132Population: The Pharmacokinetic analysis set included all subjects in the Safety set who had at least 1 evaluable post-dose pharmacokinetic measurement that was not below the limit of quantification.
Blood samples were collected for the assessment of Ctrough,max of pegcetacoplan.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=5 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=9 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Trough Serum Concentration (Ctrough,Max) of Pegcetacoplan
|
629.6 microgram per milliliter
Standard Deviation 206.66
|
679.7 microgram per milliliter
Standard Deviation 303.76
|
661.6 microgram per milliliter
Standard Deviation 192.24
|
807.8 microgram per milliliter
Standard Deviation 105.12
|
813.6 microgram per milliliter
Standard Deviation 260.08
|
795.6 microgram per milliliter
Standard Deviation 204.90
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
The FACIT-Fatigue Scale is a 13 item Likert scaled instrument where the subject was presented with 13 statements and asked to indicate their response as it applied to the past 7 days. The 5 possible responses were 'Not at all' (0), 'A little bit (1), 'Somewhat' (2), 'Quite a bit' (3) and 'Very much' (4). There are 13 statements with the total score ranging from 0 to 52 and higher scores indicating better quality of life. Mean change from baseline in FACIT-Fatigue score results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=4 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 48 and 132
Week 48
|
-3.8 score on a scale
Standard Deviation 8.38
|
10.7 score on a scale
Standard Deviation 5.51
|
0.5 score on a scale
Standard Deviation 16.33
|
9.0 score on a scale
Standard Deviation 7.07
|
—
|
—
|
|
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
-1.0 score on a scale
Standard Deviation 1.41
|
2.8 score on a scale
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Part A: Baseline (Day 1 of Part A) and Week 48; Part B: Baseline (Day 1 of Part B) and Week 132Population: The ITT analysis set included all subjects who received at least 1 dose of study drug. Only subjects analyzed at specific timepoint are reported.
The LASA consists of 5 single statements asking subjects to rate their perceived level of functioning. Specific domains include physical well-being (fatigue, activity level), emotional well-being (depression, anxiety, stress), spiritual well-being (sense of meaning), and intellectual well-being (ability to think clearly and concentrate). An item for overall quality of life is also included. Each domain scale range from 0 to 10. Where, 0 = as bad as it can be and 10 = as good as it can be. The total score ranging from 0 to 50 and higher scores indicating better quality of life. Mean change from baseline in LASA score results were summarized from Part A baseline for Part A reporting groups and from Part B baseline for Part B reporting groups.
Outcome measures
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=4 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=3 Participants
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=6 Participants
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=4 Participants
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=2 Participants
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=4 Participants
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Linear Analog Scale Assessment (LASA) Score at Weeks 48 and 132
Week 48
|
0.0 score on a scale
Standard Deviation 2.45
|
1.3 score on a scale
Standard Deviation 4.04
|
0.8 score on a scale
Standard Deviation 1.72
|
1.0 score on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Mean Change From Baseline in Linear Analog Scale Assessment (LASA) Score at Weeks 48 and 132
Week 132
|
—
|
—
|
—
|
—
|
0.0 score on a scale
Standard Deviation 0.00
|
0.5 score on a scale
Standard Deviation 1.73
|
Adverse Events
Part A: Cohort 1 wAIHA - 270 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Cohort 1 wAIHA - 360 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Cohort 2 CAD - 270 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Part A: Cohort 2 CAD - 360 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Cohort 1 wAIHA - 1080 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Cohort 2 CAD - 1080 mg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 participants at risk
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 participants at risk
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 participants at risk
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 participants at risk
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=5 participants at risk
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=9 participants at risk
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood calcium increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
Other adverse events
| Measure |
Part A: Cohort 1 wAIHA - 270 mg
n=5 participants at risk
Subjects diagnosed with wAIHA received pegcetacoplan 270 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 1 wAIHA - 360 mg
n=6 participants at risk
Subjects diagnosed with wAIHA received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 270 mg
n=7 participants at risk
Subjects diagnosed with CAD received pegcetacoplan 270 per day SC infusion up to 12 months in Part A.
|
Part A: Cohort 2 CAD - 360 mg
n=6 participants at risk
Subjects diagnosed with CAD received pegcetacoplan 360 mg per day SC infusion up to 12 months in Part A.
|
Part B: Cohort 1 wAIHA - 1080 mg
n=5 participants at risk
Eligible subjects diagnosed with wAIHA from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
Part B: Cohort 2 CAD - 1080 mg
n=9 participants at risk
Eligible subjects diagnosed with CAD from Part A entered Part B to receive pegcetacoplan 1080 mg SC infusion twice weekly (with the potential to escalate to 1080 mg every 3 days) until the subject discontinued or the development program was terminated.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
50.0%
3/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
3/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
42.9%
3/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
60.0%
3/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Memory impairment
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
3/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
2/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
22.2%
2/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Pallor
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Skin and subcutaneous tissue disorders
Venous ulcer pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
50.0%
3/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Vascular disorders
Spider vein
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
2/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
22.2%
2/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Extravascular haemolysis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Endocrine disorders
Goitre
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Endocrine disorders
Thyroid mass
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Eye disorders
Cataract
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
57.1%
4/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
2/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Fatigue
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
22.2%
2/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Infusion site pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Infusion site rash
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site bruising
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site erythema
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site pain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site pruritus
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site reaction
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Injection site swelling
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Local swelling
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Malaise
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Oedema
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Pain
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
2/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Hepatobiliary disorders
Cholelithiasis
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Ear infection
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Mastitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
40.0%
2/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
3/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
33.3%
2/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
50.0%
3/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
22.2%
2/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Pseudophakic bullous keratopathy
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
22.2%
2/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
44.4%
4/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Vitamin B complex deficiency
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
42.9%
3/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
14.3%
1/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
28.6%
2/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/7 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
16.7%
1/6 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
0.00%
0/5 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
11.1%
1/9 • Part A: TEAE data is reported from first dose of study drug (Day 1 of Part A) up to 30 days after the last dose of study drug in Part A, approximately 366 days. Part B: TEAE data is reported from first dose of study drug (Day 1 of Part B) up to 56 days after the last dose of study drug in Part B, approximately 980 days. All-cause mortality: From first dose of study drug (Day 1) up to end of the study, approximately 1346 days.
The Safety set included all subjects who received at least 1 dose of study drug. MedDRA version for Part A was 20.0 and Part B was 23.0.
|
Additional Information
Apellis Clinical Trial Information Line
Apellis Pharmaceuticals, Inc
Phone: 1-833-284-6361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place